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NCT05137730 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
NCT05137730: Completed Phase 1 study, sponsored by Takeda.
NCT05137730 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 96 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05137730, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
Study Summary
The main aim of Part I of this study is to evaluate the relative bioavailability of a new formulation compared with the approved formulation when a single dose of rhPTH(1-84) is given to healthy volunteers. Bioavailability is the ability of a drug to be absorbed and used by the body. In Part II, the main aim is to assess the dose linearity of the new formulation. Participants will receive 2 doses in Part I and 4 doses in Part II. Participants need to visit their doctor approximately 14 days and 30 days after the last dose of study drug.
Primary Outcome
AUClast was a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration.
Interventions
- DRUG rhPTH(1-84)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2021-11-29 |
| Est. Completion | 2022-04-15 |
| Phase | Phase 1 |
What the finished NCT05137730 record still lists
NCT05137730 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 1 intervention - of which rhPTH(1-84) is the first listed.
NCT05137730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05137730 about?
NCT05137730 is a clinical study titled "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". The main aim of Part I of this study is to evaluate the relative bioavailability of a new formulation compared with the approved formulation when a single dose of rhPTH(1-84) is given to healthy volunteers. Bioavailability is the ability of a drug to be absorbed and used by the body. In Part II, the...
What is the current status of trial NCT05137730?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2021-11-29. Estimated completion is 2022-04-15.
What interventions are being tested in trial NCT05137730?
The interventions under investigation include: rhPTH(1-84) (DRUG).
Who is sponsoring clinical trial NCT05137730?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05137730's enrollment target sits among peer trials
96 600th of 2000 higher than 1,391 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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