At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 54 enrolled
Drug / intervention
TAK-117 +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.
A Phase 1, Open-Label Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric pH Modification on the Pharmacokinetics of MLN1117 in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating TAK-117 and Lansoprazole for Neoplasm, Advanced or Metastatic. Completed, enrolled 54 participants.
Detailed Summary
The purpose of this study is to evaluate the relative bioavailability of a new tablet formulation of TAK-117 (new clinical trial material \[NTM\]) compared to the TAK-117 Process B capsules (current clinical trial material \[CTM\]) (Part 1), to assess the effects of food on the oral bioavailability and pharmacokinetics (PK) of TAK-117 (Part 2), and to assess the effects of gastric pH-modifying agent on the PK of TAK-117 in healthy participants (Part 3).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasm, Advanced or Metastatic
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartJan 2016
Primary CompletionMay 2016
Study CompletionJul 2016
TodayJul 2026
First PostedDec 9, 2015
Enrollment StartJan 8, 2016
Primary CompletionMay 16, 2016
Study CompletionJul 22, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.6 years ago
Interventions
TAK-117drug
TAK-117 capsules
Lansoprazoledrug
Lansoprazole capsules
TAK-117drug
TAK-117 tablets