NCT04208061

A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants

A Phase 1, 2-Panel, Fixed-Sequence, Open-Label Single-Center Study to Assess the Effect of Single and Multiple Doses of Darunavir in Combination With Cobicistat or Ritonavir on the Pharmacokinetics of Single Dose Dabigatran Etexilate in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate effect of single and repeated doses of darunavir (DRV) in combination with cobicistat (DRV/COBI) and with ritonavir (DRV+rtv) on the pharmacokinetics of single dose dabigatran etexilate (measured in plasma as free and total dabigatran) when co-administered in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Dabigatran Etexilate	Participants will receive single dose of dabigatran etexilate orally.
DRUG	DRV/COBI	Participants will receive oral tablet of fixed dose combination (FDC) containing darunavir (DRV)/ cobicistat (COBI).
DRUG	Ritonavir	Participants will receive ritonavir orally.
DRUG	Darunavir	Participants will receive Darunavir orally.

Timeline

• Start date: 2019-12-18
• Primary completion: 2021-03-25
• Completion: 2021-04-01
• First posted: 2019-12-23
• Last updated: 2025-02-03

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study