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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 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 54 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02396147
The ClinicalTrials.gov registry entry for NCT02396147 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 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 3 interventions - of which TAK-385 T2 Formulation is the first listed.
NCT02396147 reports 0 study locations.
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.
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