NCT03438461

A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Participants Under Fasted and Semi-fasted Conditions

A Randomized, Open-label, Single-dose, 6-Period, 8-Sequence Crossover Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Subjects Under Fasted and Semi-fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess and compare the pharmacokinetics (PK) and relative oral bioavailability of 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Seltorexant 40 mg	Seltorexant 40 mg as two tablets of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 1.
DRUG	Seltorexant 20 mg	Seltorexant as a tablet of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 2.

Timeline

• Start date: 2018-02-09
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2018-02-19
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study