NCT02945020

A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants

A Phase 1, Open-label, Sequential Study to Investigate the Pharmacokinetic Interaction Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), as a single agent or in combination with simeprevir (SMV), on the single-dose pharmacokinetics of dabigatran etexilate in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Dabigatran etexilate mesylate	Participants will receive dabigatran etexilate mesylate 75 mg, orally.
DRUG	Odalasvir (ODV)	Participants will receive ODV 25 mg, orally.
DRUG	Simeprevir (SMV)	Participants will receive SMV 75 mg, orally.

Timeline

• Start date: 2016-11-10
• Primary completion: 2017-01-09
• Completion: 2017-01-20
• First posted: 2016-10-26
• Last updated: 2025-02-03

Locations

1 site across 1 country: United States