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NCT02396147 · ClinicalTrials.gov registry record · Phase 1
Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT02396147: Completed Phase 1 study, sponsored by Takeda.
NCT02396147 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02396147, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the oral bioavailability of two new tablet formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4 Formulation C tablet.
Interventions
- DRUG TAK-385 T2 Formulation
- DRUG TAK-385 T4 Formulation B
- DRUG TAK-385 T4 Formulation C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT02396147 record still lists
NCT02396147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 3 interventions - of which TAK-385 T2 Formulation is the first listed.
NCT02396147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02396147 about?
NCT02396147 is a clinical study titled "Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants". The purpose of this study is to evaluate the oral bioavailability of two new tablet formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the pharmacokinetics (PK) of a single oral do...
What is the current status of trial NCT02396147?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2015-03. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02396147?
The interventions under investigation include: TAK-385 T2 Formulation (DRUG), TAK-385 T4 Formulation B (DRUG), TAK-385 T4 Formulation C (DRUG).
Who is sponsoring clinical trial NCT02396147?
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 NCT02396147's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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