A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants

The requested reference [8675e119d7484c10cbca0cfa53c11368b44efb4b] no longer exists in our database. It has been replaced by the current reference: [4d5bdd0d4ab686086a0c2e042a2955d8ad746186]

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
The drug being tested in this study is called TAK‐831. TAK‐831 is being tested in healthy participants to evaluate the relative BA and effect of food on the PK of TAK‐831 tablet formulation. The study will enroll approximately 16 participants. Participants will be randomly assigned (by chance, like flipping a coin) to TAK‐831 in 1 of the 4 treatment sequences as following: ‐ T2 50 mg Fasted + T3 50 mg Fasted + T2 600 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed ‐ T3 50 mg Fasted + T2 600 mg Fasted + T2 50 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed ‐ T2 600 mg Fasted + T3 600 mg Fasted + T3 50 mg Fasted + T2 50 mg Fasted + T3 600 mg Fed ‐ T3 600 mg Fasted + T2 50 mg Fasted + T2 600 mg Fasted + T3 50 mg Fasted + T3 600 mg Fed All participants will be asked to take tablet of assigned TAK‐831 on Day 1 of each treatment period. This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 70 days. Participants will make multiple visits to the clinic and will be contacted by clinic approximately 14 days after the last dose of study drug for a follow‐up assessment.
Epistemonikos ID: 2efbb15b9e1c472bf2f2022ee78de07be2dcb3a3
First added on: May 21, 2024