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Calcitriol

Phase 1

Healthy | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 15, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

Calcitriol · 1 trial · 1 indication

Phase 1 1
NCT00925704The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy VolunteersHealthy
COMPLETED41 Analytics
PHASE1COMPLETED
The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol
pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose

This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.

Secondary Endpoints

Maximum Plasma Concentration (Cmax) for Exogenous Calcitriol
pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose
Time of Maximum Plasma Concentration (Tmax) for Exogenous Calcitriol
pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
CalcitriolACTIVE_COMPARATOR -
Lanthanum carbonate + calcitriolEXPERIMENTAL -
Sevelamer carbonate + calcitriolEXPERIMENTAL -

Interventions

NameTypeDescription
CalcitriolDRUGCalcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
Lanthanum carbonate + CalcitriolDRUGLanthanum carbonate (1000 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
Sevelamer carbonate + CalcitriolDRUGSevelamer carbonate (2400 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
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Eligibility Criteria

Age Range19 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria * Healthy volunteers age 19-45 years inclusive at the time of consent. * Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, electrocardiogram (ECG) and laboratory evaluation (hematology, ...

Countries:United States
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Frequently asked questions about Calcitriol

What is Calcitriol used for?

Calcitriol is a small molecule being studied in healthy volunteers. It is the active form of vitamin D and is being investigated for its pharmacokinetics when administered alone or in combination with other drugs. The drug is currently in Phase 1 clinical development.

Who makes Calcitriol?

Calcitriol is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to study the drug's pharmacokinetics in healthy volunteers.

What phase is Calcitriol in?

Calcitriol is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its pharmacokinetics.

What clinical trials is Calcitriol in?

Calcitriol has one completed Phase 1 clinical trial, NCT00925704, which studied the pharmacokinetics of Rocaltrol when administered alone or in combination with Fosrenol or Renvela in healthy volunteers. The trial enrolled 41 participants in the United States.

Is Calcitriol the same as Rocaltrol?

Yes, Calcitriol is also known as Rocaltrol. The clinical trial NCT00925704 specifically studied the pharmacokinetics of Rocaltrol, which is the brand name for Calcitriol, when given alone or with other medications.