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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 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 96 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05137730
The ClinicalTrials.gov registry entry for NCT05137730 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rhPTH(1-84) is the first listed.
NCT05137730 reports 0 study locations.
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.
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