CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
25mcg rhPTH(1-84) +2 moredrug
Likely dose
25mcg rhPTH(1-84)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02781844
NCT02781844Phase 1Completed
CompareCT.gov

An Open-Label, Randomized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once Daily and Twice Daily Dose Regimens of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) Administered Subcutaneously to Subjects With Hypoparathyroidism

Shire·interventional·Posted May 25, 2016·Updated May 25, 2021

In Brief

A Phase 1 clinical trial evaluating 25mcg rhPTH(1-84), 50mcg rhPTH(1-84), and 1 other intervention for Hypoparathyroidism. Completed, enrolled 34 participants across 15 sites in 4 countries.

Detailed Summary

This study is being conducted to characterize the effects of twice daily administration of rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and tolerability over the course of 24 hours as compared with the current once daily dosing regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara® and in the EU as Natpar).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoparathyroidism
CountriesCanada, Denmark, Hungary, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 25, 2016
Enrollment StartApr 3, 2017
Primary CompletionMar 8, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.1 years ago

Interventions

25mcg rhPTH(1-84)drug

Participants 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)drug

Participants 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)drug

Participants 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.