CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
TAK-935 Tablets +1 moredrug
Likely dose
Not stated in record
Key inclusion· 1
  • ✓Weight ≥45 kg and BMI 18.0–30.0 kg/m² at Screening and Day -2
Key exclusion· 8
  • ✕Prior exposure to TAK-935 in any clinical study or as a therapeutic agent
  • ✕History of psychiatric disorder per DSM-5 criteria
  • ✕Lifetime history of drug abuse (illicit drug use) or alcohol abuse; unwilling to abstain from alcohol and drugs during study
  • ✕History of cancer except basal cell carcinoma in remission ≥5 years before Day 1

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

Search/NCT02906813
NCT02906813Phase 1Completed
CompareCT.gov

A Phase 1 Bioavailability and Food Effect Study to Compare Tablet Versus Solution Formulation and to Assess the Effect of Food on the Bioavailability of a Single TAK-935 Dose in Healthy Subjects

Takeda·interventional·Posted Sep 20, 2016·Updated Sep 19, 2018

In Brief

A Phase 1 clinical trial evaluating TAK-935 Tablets and TAK-935 Oral Solution for Healthy Volunteers. Completed, enrolled 9 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

Study Details

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

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 20, 2016
Enrollment StartSep 12, 2016
Primary CompletionOct 12, 2016
Study CompletionNov 9, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 9.8 years ago

Interventions

TAK-935 Tabletsdrug

Tablets

TAK-935 Oral Solutiondrug

Oral solution