CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 88 enrolled
Drug / intervention
TAK-915 suspension +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02461160
NCT02461160Phase 1Completed
CompareCT.gov

A Phase 1 Safety, Tolerability, Pharmacokinetic, Placebo-Controlled and Open-Label Study of Escalating Single and Multiple Oral Doses, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Subjects of TAK-915 in Healthy Subjects

Takeda·interventional·Posted Jun 3, 2015·Updated Feb 15, 2019

In Brief

A Phase 1 clinical trial evaluating TAK-915 suspension, Midazolam, and 2 other interventions for Healthy Volunteers. Completed, enrolled 88 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 3, 2015
Enrollment StartMay 12, 2015
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.1 years ago

Interventions

TAK-915 suspensiondrug

TAK-915 oral suspension

Midazolamdrug

Midazolam oral solution

Placebodrug

Placebo-matching TAK-915 suspension

TAK-915 tabletdrug

TAK-915 tablet