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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Healthy
Interventions
DRUG

Drospirenone/ethinylestradiol

Each tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol to be taken orally on Days 1, 6, 25, and 32.

DRUG

AL-335

AL-335 (800 mg) tablet once daily on Days 5-7 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.

DRUG

Odalasvir (ODV)

ODV 25 mg tablet once daily on Days 12-25 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.

DRUG

Simeprevir (SMV)

SMV 75 mg capsule as a component of 3-DAA combination to be taken orally on Days 26-32.

Trial Locations (1)

Unknown

Overland Park

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter