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NCT02790684 · ClinicalTrials.gov registry record · Phase 1
A Study Assessing the Mass Balance of a Single Oral Dose of [14C] DS-8500a in Healthy Subjects
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02790684: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT02790684 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02790684, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age, inclusive. The radiolabeled investigational medicinal product will be administered to 12 healthy male subjects in 2 cohorts of 6 subjects each.
Primary Outcome
to determine mass balance (excretion) of DS-8500a
Interventions
- DRUG DS-8500a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-05 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02790684 record still lists
NCT02790684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which DS-8500a is the first listed.
NCT02790684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02790684 about?
NCT02790684 is a clinical study titled "A Study Assessing the Mass Balance of a Single Oral Dose of [14C] DS-8500a in Healthy Subjects". This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age, inclusive. The radiolabeled investigational medicinal product will be administered to 12 healthy male subjects in 2 c...
What is the current status of trial NCT02790684?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2016-05. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02790684?
The interventions under investigation include: DS-8500a (DRUG).
Who is sponsoring clinical trial NCT02790684?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02790684's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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