A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Escalating Dose Trial in Healthy Participants to Assess Pharmacokinetics, Safety, and Tolerability of TEV-56286 at Clinical and Supratherapeutic Doses

Summary

The purpose of the trial is to evaluate the pharmacokinetics, safety, and tolerability of TEV-56286 at different doses. The main objective is to describe how TEV-56286 is absorbed, distributed, and removed from the body (the pharmacokinetics) following administration of TEV-56286 in single doses of increasing amounts and multiple doses in healthy participants. A secondary objective is to assess the safety of TEV-56286 and how well it is tolerated. The estimated duration for participants in Part 1 with Single Ascending Dose is approximately 58 days; including up to 45 days of screening, a 4-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit. The estimated duration for participants in Part 2 with Multiple Dose is approximately 64 days; including 45 days of screening, a 10-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.

Eligibility

Age range

18–60 years

Sex

All

Healthy volunteers

Yes

Interventions

• Drug
  TEV-56286 Dose A

  oral administration

• Drug
  TEV-56286 Dose B

  oral administration

• Drug
  TEV-56286 Dose C

  oral administration

• Drug
  TEV-56286 Dose D

  oral administration

• Drug
  TEV-56286 Dose E

  oral administration

• Drug
  Placebo

  matching placebo

Location