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
Abstract
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).
Conditions: Neoplasm, Advanced or Metastatic.
Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-117; Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117; AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117.
Enrollment: 54 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 54 participants or records.
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