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

NCT ID: NCT02885454

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-12-31

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

OC + AL-335 + ODV + 3-DAA combination

Participants will receive single dose of 3 milligram (mg) drospirenone/0.02 mg ethinylestradiol \[OC\] on Day 1, AL-335 800 mg once daily on Days 5 and 6, a single dose of AL-335 800 mg + a single dose of OC on Day 7, ODV 25 mg once daily on Days 12 to 24, followed by a single dose of ODV 25 mg and a single dose of OC on Day 25, followed by ODV 25 mg + AL-335 800 mg + simeprevir (SMV) 75 mg \[3-DAA combination\] once daily on Days 26 to 31, followed by a single dose of 3-DAA combination and a single dose of OC on Day 32.

Group Type: EXPERIMENTAL

Drospirenone/ethinylestradiol

Intervention Type: DRUG

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

AL-335

Intervention Type: DRUG

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.

Odalasvir (ODV)

Intervention Type: DRUG

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.

Simeprevir (SMV)

Intervention Type: DRUG

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

Interventions

Drospirenone/ethinylestradiol

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Simeprevir (SMV)

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

Intervention Type: DRUG

Other Intervention Names

Yaz®

Eligibility Criteria

Inclusion Criteria

• Participant must be a female of childbearing potential with a normal menstrual cycle
• Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) between 18.0 and 30.0 kilogram per square meter (kg/m^2), extremes included, and a body weight not less than 50.0 kilogram (kg)
• Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
• Participant must have a negative serum (beta human chorionic gonadotropin [beta- hCG]) pregnancy test at screening
• Participant must have a negative highly sensitive urine pregnancy test at Day -1

Exclusion Criteria

• Participant is peri- or postmenopausal, or participant with bilateral oophorectomia
• Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
• Participant has previously been dosed with simeprevir (SMV), odalasvir (ODV), or AL-335 in more than 3 single dose studies, or a multiple-dose study with SMV, ODV, or AL-335
• Participant with currently active gynecological disorders including, but not limited to, vaginal bleeding without an obvious reason and hyperprolactinemia with or without galactorrhea
• Participant with a past history of: heart arrhythmias (example, extrasystolic rhythms or tachycardia at rest). Isolated extrasystolic beats are not exclusionary; risk factors associated with Torsade de Pointes such as hypokalemia; family history of short/long QT syndrome; sudden unexplained death (including sudden infant death syndrome [SIDS]) in a first-degree relative (that is, sibling, offspring, or biological parent)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

64294178HPC1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108177

Identifier Type: -

Identifier Source: org_study_id