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NCT02461160 · ClinicalTrials.gov registry record · Phase 1
Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study
A Phase 1 study of Healthy Volunteers, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT02461160: Completed Phase 1 study of Healthy Volunteers, sponsored by Takeda.
NCT02461160 is a Phase 1 study of Healthy Volunteers that has completed, run by Takeda. The registered enrollment target is 88 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02461160, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to characterize the safety, tolerability and plasma pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral suspension doses at escalating dose levels in healthy participants, including elderly participants.
Primary Outcome
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Midazolam
- DRUG TAK-915 suspension
- DRUG TAK-915 tablet
Study Locations (1)
Texas
- - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2015-05-12 |
| Est. Completion | 2016-08-01 |
| Phase | Phase 1 |
What the finished NCT02461160 record still lists
NCT02461160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02461160 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02461160 about?
NCT02461160 is a clinical study titled "Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study". The purpose of this study is to characterize the safety, tolerability and plasma pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral suspension doses at escalating dose levels in healthy participants, including elderly participants.
What is the current status of trial NCT02461160?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2015-05-12. Estimated completion is 2016-08-01.
What conditions does trial NCT02461160 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT02461160?
The interventions under investigation include: Placebo (DRUG), Midazolam (DRUG), TAK-915 suspension (DRUG), TAK-915 tablet (DRUG).
Who is sponsoring clinical trial NCT02461160?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02461160 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02461160's enrollment target sits among peer trials
88 84th of 283 higher than 200 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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