At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 69 enrolled
Drug / intervention
TAK-788 +2 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.
Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Rising Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of TAK-788 Followed by Open-Label, Crossover Evaluation of the Effects of a Low-Fat Meal on TAK-788 Pharmacokinetics and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating TAK-788 and Placebo for Healthy Volunteers. Completed, enrolled 69 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartMar 2018
First PostedMar 2018
Primary CompletionDec 2018
Study CompletionJan 2019
TodayJul 2026
First PostedMar 29, 2018
Enrollment StartMar 28, 2018
Primary CompletionDec 22, 2018
Study CompletionJan 18, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.3 years ago
Interventions
TAK-788drug
TAK-788 capsules.
Placebodrug
TAK-788 placebo-matching capsules.
TAK-788drug
TAK-788 DiC.