Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study

Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study

NCT ID: NCT02748694 Phase: PHASE1 Status: COMPLETED Enrollment: 114 Completion: 2019-09-22

Conditions

Healthy Volunteers, Schizophrenia

Interventions

TAK-041, TAK-041 Placebo

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041:

  1. Following oral single and multiple doses in healthy participants.
  2. As add-on therapy to antipsychotics in stable schizophrenia participants.
  3. To determine the oral bioavailability of the TAK-041 tablet formulation compared to the oral suspension formulation in the fasted state.
  4. To assess the effect of food on the PK of TAK-041 in healthy participants.

Primary Outcome

Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)

Source

ClinicalTrials.gov