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NPSP795

Phase 2

Autosomal Dominant Hypocalcemia (ADH) | Small molecule | Rare Disease |Takeda Pharmaceutical Company Limited|Last Updated: Aug 9, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

NPSP795 · 1 trial · 1 indication

Phase 2 1
NCT02204579A Study to Determine the Effects of NPSP795 on the Calcium-sensing Receptor in Subjects With Autosomal Dominant Hypocalcemia as Measured by PTH Levels and Blood Calcium ConcentrationsAutosomal Dominant Hypocalcemia (ADH)
COMPLETED7 Analytics
PHASE2COMPLETED
A Study to Determine the Effects of NPSP795 on the Calcium-sensing Receptor in Subjects With Autosomal Dominant Hypocalcemia as Measured by PTH Levels and Blood Calcium Concentrations
Autosomal Dominant Hypocalcemia (ADH)
NCT022045797
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Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities
From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
Number of Participants With Potentially Clinically Important Laboratory Abnormalities
From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
Number of Participants With Clinically Significant Abnormalities Related to Physical Examination
From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
Change From Baseline in Ionised Calcium
10 Minute (min) Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, and 2, 2.5, 3, 3.5, & 4 hour (hr) 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, & 2, 2.5, 3, 3.5, 4, 5, and 8 hr
Change From Baseline in Serum Calcium
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr.
Change From Baseline in Urinary Calcium
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr.
Change From Baseline in Serum Parathyroid Hormone (PTH)
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr

Secondary Endpoints

Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr
Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr
Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NPSP795EXPERIMENTALintravenous

Interventions

NameTypeDescription
NPSP795DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects with a heterozygous activating mutation of the CaSR gene (ADH); if not previously confirmed, genetic testing will be performed at the screening visit * At least 18 years of age * Body mass index (BMI) ≥ 18.5 to \< 39 kg/m2 Exclusion Criteria: * Diseases or condition...

Countries:United States
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Frequently asked questions about NPSP795

What is NPSP795 used for in Autosomal Dominant Hypocalcemia?

NPSP795 is an investigational small molecule being studied for the treatment of Autosomal Dominant Hypocalcemia (ADH), a rare genetic disorder characterized by low blood calcium levels. It is designed to act on the calcium-sensing receptor to help regulate calcium and parathyroid hormone levels in patients with this condition.

What does NPSP795 target?

NPSP795 targets the calcium-sensing receptor, which plays a key role in maintaining calcium homeostasis in the body. By modulating this receptor, the drug aims to correct the abnormal calcium and parathyroid hormone levels seen in Autosomal Dominant Hypocalcemia (ADH).

Who makes NPSP795?

NPSP795 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Autosomal Dominant Hypocalcemia.

What phase is NPSP795 in?

NPSP795 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness for treating Autosomal Dominant Hypocalcemia (ADH).

What clinical trials is NPSP795 in?

NPSP795 has been studied in one completed Phase 2 clinical trial, identified as NCT02204579. This trial enrolled 7 adult participants with Autosomal Dominant Hypocalcemia in the United States and evaluated the drug's effects on calcium-sensing receptor activity, as measured by parathyroid hormone levels and blood calcium concentrations.

Is NPSP795 the same as any other drug?

NPSP795 is the primary name for this investigational compound. No alternative names have been established for this drug in the available clinical trial information. It is being studied specifically for Autosomal Dominant Hypocalcemia and is not known to be marketed under any other brand name.