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NCT03482453 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT03482453: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT03482453 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03482453, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative to a reference (Process A) DiC of TAK-788 in healthy participants.
Interventions
- DRUG Placebo
- DRUG TAK-788
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2018-03-28 |
| Est. Completion | 2019-01-18 |
| Phase | Phase 1 |
What the finished NCT03482453 record still lists
NCT03482453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03482453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03482453 about?
NCT03482453 is a clinical study titled "A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants". The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evalua...
What is the current status of trial NCT03482453?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2018-03-28. Estimated completion is 2019-01-18.
What interventions are being tested in trial NCT03482453?
The interventions under investigation include: Placebo (DRUG), TAK-788 (DRUG).
Who is sponsoring clinical trial NCT03482453?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03482453's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 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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