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rhPTH

Phase 1

Healthy Volunteers | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Dec 15, 2023

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

rhPTH · 3 trials · 2 indications

Phase 1 3
NCT05137730A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy AdultsHealthy Volunteers
COMPLETED96 Analytics
NCT03150108Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult SubjectsHypoparathyroidism
COMPLETED24 Analytics
NCT02781844Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With HypoparathyroidismHypoparathyroidism
COMPLETED34 Analytics
PHASE1COMPLETED
A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy Adults
Healthy Volunteers
NCT0513773096
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PHASE1COMPLETED
Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects
Hypoparathyroidism
NCT0315010824
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PHASE1COMPLETED
Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism
Hypoparathyroidism
NCT0278184434
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Study Endpoints

Primary Endpoints

Part I: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of rhPTH (1-84)
Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose

AUClast was a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration.

Part II: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of rhPTH (1-84)
Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose

AUClast was a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration.

Part I: Area Under the Plasma Concentration- Time Curve From Time Zero to Infinity (AUCinf) of rhPTH(1-84)
Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose

AUCinf was the area under the curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration. AUC was be used as a measure of drug exposure. It was derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Part II: Area Under the Plasma Concentration- Time Curve From Time Zero to Infinity (AUCinf) of rhPTH(1-84)
Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose

AUCinf was the area under the curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration. AUC was be used as a measure of drug exposure. It was derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Part I: Maximum Observed Plasma Concentration (Cmax) of rhPTH(1-84)
Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose

Cmax referred to the maximum (or peak) concentration that a drug achieved in the body after the drug had been administrated.

Part II: Maximum Observed Plasma Concentration (Cmax) of rhPTH(1-84)
Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose

Cmax referred to the maximum (or peak) concentration that a drug achieved in the body after the drug had been administrated.

Number of Participants With Clinically Significant Changes in Vital Signs Values
From start of study drug administration up to Day 34

Vital sign assessments included systolic and diastolic blood pressure, pulse rate and body temperature. Any change in vital signs which are deemed clinically significant by the investigator were reported.

Baseline-adjusted Cmax of PTH(1-84)
30 and 90 minutes (min) Pre-dose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours (h) Post-dose

Baseline-adjusted maximum observed drug concentration (Cmax) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Baseline-adjusted Tmax of PTH(1-84)
30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted time to reach maximum observed drug concentration (Tmax) of PTH(1-84) in plasma was reported.

Baseline-adjusted AUC(Last) of PTH(1-84) in Plasma
30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted area under the curve from the time of dosing to the last measurable concentration (AUC(last)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Baseline-adjusted AUC(0-8) of PTH(1-84) in Plasma
30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted area under the concentration versus time curve from the time of dosing to 8 hours post dose (AUC(0-8)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Baseline-adjusted AUC(0-inf) of PTH(1-84) in Plasma
30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted area under the concentration versus time curve extrapolated to infinity (AUC(0-inf)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Baseline- Adjusted % of AUC(0-Inf) Extra of PTH(1-84) in Plasma
30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted % of AUC extrapolated from the last measurable concentration to infinity over (AUC(0-Inf)) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Baseline-adjusted Lambda_z of PTH(1-84) in Plasma
30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted Lambda z associated with the terminal (log-linear) portion of the curve for PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Baseline-adjusted t1/2 of PTH(1-84) in Plasma
30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted Terminal Half-life (t1/2) of PTH(1-84) in plasma was reported.

Baseline-adjusted CL/F of PTH(1-84) in Plasma
30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted apparent clearance (CL/F) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Baseline-adjusted Vdz/F of PTH(1-84) in Plasma
30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted apparent volume of distribution (Vdz/F) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84)
QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose ; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose

Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Tmax of baseline adjusted rhPTH(1-84) was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84)
QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose

Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Cmax of baseline adjusted rhPTH(1-84) was reported.

Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Baseline Adjusted rhPTH(1-84)
QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose

Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUClast of baseline adjsuted plasma rhPTH(1-84) was reported.

Area Under the Curve Extrapolated to Infinity (AUCinf) of Baseline Adjusted rhPTH(1-84)
QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose

Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUCinf of baseline adjusted rhPTH(1-84) was reported.

Area Under the Concentration Curve From Time Zero to 24 Hours Post the First Dose (AUC0-24) of Baseline Adjusted rhPTH(1-84)
QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose

Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC0-24 of baseline adjusted rhPTH(1-84) was reported.

Area Under the Concentration Curve From Time Zero to 12 Hours Post the First Dose (AUC0-12) of Baseline Adjusted rhPTH(1-84)
BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours post-dose

Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC0-12 of baseline adjusted rhPTH(1-84) was reported. AUC(0-12) was planned, analyzed and reported only in participants who received BID treatment ( Treatment A, Treatment C, Treatment D, Treatment F).

Area Under the Concentration Curve From Time of the Second Dose to 12 Hours Post the Second Dose (AUC12-24) of Baseline Adjusted rhPTH(1-84)
BID: 12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose

Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC12-24 of baseline adjusted rhPTH(1-84) was reported. AUC(12-24) was planned, analyzed and reported only in participants who received BID treatment ( Treatment A, Treatment C, Treatment D, Treatment F).

Terminal Half-Life (t1/2) of Baseline Adjusted rhPTH(1-84)
QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose

Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. T1/2 of baseline adjusted rhPTH(1-84) was reported.

Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day -1
Day -1

Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCabove of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium \[uncorrected\]) concentrations on Day -1 was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day -1
Day -1

Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCbelow of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium \[uncorrected\]) concentrations on Day -1 was reported.

Time to Maximum Effect (TEmax) of Baseline-Adjusted Serum Calcium Concentrations on Day -1
Day -1

Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. TEmax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium \[uncorrected\]) concentrations on Day -1 were reported.

Maximum Effect (Emax) of Baseline-Adjusted Serum Calcium Concentrations on Day -1
Day -1

Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. Emax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium \[uncorrected\]) concentrations on Day -1 were reported.

Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2
Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose

Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCabove of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium \[uncorrected\]) concentrations on Day 1/Day 2 were reported.

Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2
Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose

Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCbelow of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium \[uncorrected\]) concentrations on Day 1/Day 2 was reported.

Time to Maximum Effect (TEmax) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2
Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose

Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. TEmax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium \[uncorrected\]) concentrations on Day 1/Day 2 were reported.

Maximum Effect (Emax) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2
Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose

Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. Emax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium \[uncorrected\]) concentrations on Day 1/Day 2 were reported.

Total Amount of Urinary Calcium Excretion to Total Relative Amount of Creatinine Over 24 Hours by Day -1
Day -1

Total amount of urinary calcium excretion to total relative amount of creatinine over 24 hours by Day -1 was reported.

Total Amount of Urinary Calcium Excretion to Total Relative Amount of Creatinine Over 24 Hours by Day 1/ Day 2
Day 1- QD: Pre-dose up to 24 hours post dose, Day 2- BID: Pre-dose up to 24 hours post dose

Total amount of urinary calcium excretion to total relative amount of creatinine over 24 hours by Day 1/ Day 2 was reported.

Total Urinary Excretion of Calcium Over 24 Hours by Day -1
Day -1

Total urinary excretion of calcium over 24 Hours by Day -1 was reported.

Total Urinary Excretion of Calcium Over 24 Hours by Day 1/ Day 2
Day 1- QD: Pre-dose up to 24 hours post dose, Day 2- BID: Pre-dose up to 24 hours post dose

Total urinary excretion of calcium over 24 hours by Day1/Day 2 was reported.

Secondary Endpoints

Part I and II: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
From start of study drug administration up to Day 34
Part I and II: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters Reported as TEAEs
From start of study drug administration up to Day 34
Part I and II: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
From start of study drug administration up to Day 34
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Part I: Sequence ABEXPERIMENTALParticipants will receive a single SC injection of 100 microgram (mcg) rhPTH(1-84) (Formulation A) on Day 1 of treatment period 1 followed by 100 mcg rhPTH(1-84) (Formulation B) on Day 1 of treatment period 2. A washout period of 96 hours will be maintained between each treatment period.
Part I: Sequence BAEXPERIMENTALParticipants will receive a single SC injection of 100 microgram (mcg) rhPTH(1-84) (Formulation B) on Day 1 of treatment period 1 followed by 100 mcg rhPTH(1-84) (Formulation A) on Day 1 of treatment period 2. A washout period of 96 hours will be maintained between each treatment period.
Part II: Sequence CDEFEXPERIMENTALParticipants will receive a single SC injection of 25 mcg (dose C) rhPTH(1-84) on Day 1 of treatment period 1 followed by 50 mcg (dose D) rhPTH(1-84) on Day 1 of treatment period 2 followed by 75 mcg (dose E) rhPTH(1-84) on Day 1 of treatment period 3 followed 200 mcg (dose F) rhPTH(1-84) on Day 1 of treatment period 4. A washout period of 48 hours will be maintained between each treatment period 1,2,3 and 4.
Part II: Sequence DFCEEXPERIMENTALParticipants will receive a single SC injection of 50 mcg (dose D) rhPTH(1-84) on Day 1 of treatment period 1 followed by 200 mcg (dose F) rhPTH(1-84) on Day 1 of treatment period 2 followed by 25 mcg (dose C) rhPTH(1-84) on Day 1 of treatment period 3 followed by 75 mcg (dose E) rhPTH(1-84) on Day 1 of treatment period 4. A washout period of 48 hours will be maintained between each treatment period 1,2,3 and 4.
Part II: Sequence ECFDEXPERIMENTALParticipants will receive a single SC injection of 75 mcg (dose E) rhPTH(1-84) on Day 1 of treatment period 1 followed by 25 mcg (dose C) rhPTH(1-84) on Day 1 of treatment period 2 followed by 200 mcg (dose F) rhPTH(1-84) on Day 1 of treatment period 3 followed by 50 mcg (dose D) rhPTH(1-84) on Day 1 of treatment period 4. A washout period of 48 hours will be maintained between each treatment period 1,2,3 and 4.
Part II: Sequence FEDCEXPERIMENTALParticipants will receive a single SC injection of 200 mcg (dose F) rhPTH(1-84) on Day 1 of treatment period 1 followed by 75 mcg (dose E) rhPTH(1-84) on Day 1 of treatment period 2 followed by 50 mcg (dose D) rhPTH(1-84) on Day 1 of treatment period 3 followed by 25 mcg (dose C) rhPTH(1-84) on Day 1 of treatment period 4. A washout period of 48 hours will be maintained between each treatment period 1,2,3 and 4.
Non-Hispanic CaucasiansEXPERIMENTALSubjects will receive single dose of 100 microgram (mcg) rhPTH(1-84) subcutaneous (SC) injection on Day 1.
Participants of Japanese DescentEXPERIMENTALSubjects will receive single dose of 100 mcg rhPTH(1-84) SC injection on Day 1; On days 4 and 7, either 25 mcg or 50 mcg SC injection. A washout period of 73 hours will be maintained between each single doses (100 mcg, 50 mcg and 25 mcg) in a cross-over fashion.
A/B or B/AEXPERIMENTALParticipants will be randomized to either receive 25 microgram (mcg) rhPTH(1-84) twice daily with no calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with no calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with no calcium for treatment period 1 and 25mcg rhPTH(1-84) BID with no calcium for treatment period 2
C/B or B/CEXPERIMENTALParticipants will be randomized to either receive 50mcg rhPTH(1-84) twice daily with no calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with no calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with no calcium for treatment period 1 and 50mcg rhPTH(1-84) twice daily with no calcium for treatment period 2
D/E or E/DEXPERIMENTALParticipants will be randomized to either receive 25mcg rhPTH(1-84) twice daily with calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with calcium for treatment period 1 and 25mcg rhPTH(1-84) twice daily with calcium for treatment period 2
F/E or E/FEXPERIMENTALParticipants will be randomized to either receive 50mcg rhPTH(1-84) twice daily with calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with calcium for treatment period 1 and 50mcg rhPTH(1-84) twice daily with calcium for treatment period 2

Interventions

NameTypeDescription
rhPTH(1-84)DRUGParticipants in both part I and part II of the study will receive a single SC injection of rhPTH(1-84) depending upon the treatment sequence allocation on Day 1 of each treatment period.
25mcg rhPTH(1-84)DRUGParticipants will receive rhPTH(1-84) as twice-daily regimen (12 hours apart) of two 25mcg doses without calcium in cohort 1 and with calcium in cohort 3.
50mcg rhPTH(1-84)DRUGParticipants will receive rhPTH(1-84) as twice daily regimen (12 hours apart) of two 50mcg doses without calcium in cohort 2 and with calcium in cohort 4
100mcg rhPTH(1-84)DRUGParticipants will receive rhPTH(1-84) as once-daily regimen of one 100 mcg dose without calcium in cohort 1 and 2 and with calcium in cohort 3 and 4 in the morning.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Participants must fulfill all of the following inclusion criteria to be eligible for participation in the study: * Healthy, adult, male or female, 18-65 years of age, inclusive, at screening. Attempts will be made to enroll at least 20% of each sex in each study part. * Continu...

Countries:United StatesCanadaDenmarkHungary
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Frequently asked questions about rhPTH

What is rhPTH used for?

rhPTH is an investigational recombinant human parathyroid hormone being studied for hypoparathyroidism and in healthy volunteers. It is in Phase 1 clinical development by Takeda Pharmaceutical Company Limited (TAK). The drug is being evaluated for its blood concentrations and actions when given to participants with hypoparathyroidism.

Who makes rhPTH?

rhPTH is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 1 clinical trials for hypoparathyroidism and in healthy volunteer studies.

What phase is rhPTH in?

rhPTH is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, studying the drug in participants with hypoparathyroidism and in healthy volunteers.

What clinical trials is rhPTH in?

rhPTH has been studied in three completed Phase 1 trials: NCT02781844 assessed blood concentrations and actions in hypoparathyroidism patients, NCT03150108 compared Japanese and Caucasian healthy subjects, and NCT05137730 evaluated relative bioavailability of a new formulation in healthy adults.

Is rhPTH the same as rhPTH(1-84)?

Yes, rhPTH is also referred to as rhPTH(1-84) and recombinant human parathyroid hormone. Clinical trials use these names interchangeably, such as in NCT02781844 which studies rhPTH [1-84] in hypoparathyroidism participants.