drugset / Trial / NCT02885454

To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants

NCT02885454

Phase 1 Completed 24 enrolled Janssen Research & Development, LLC
NaSingle-groupOpen-labelOther

Summary

The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA) ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and ethinylestradiol in healthy female participants.

Timeline

Start
2016-08
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject ADAFOSBUVIR Small molecule 800 mg Oral
Subject Odalasvir Small molecule 25 mg Oral
Subject Simeprevir Small molecule 75 mg Oral
Subject drospirenone Unknown 3 mg Oral
Subject ethinyl estradiol Small molecule 0.02 mg Oral

Indications

No indication recorded.