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 | Completed Phase 1

• 2 other identifiers: CR10817764294178HPC1001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Analyte Concentration (Cmax) of Drospirenone

  Cmax is the maximum observed analyte concentration.

  Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Drospirenone

  The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

  Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Drospirenone

  The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

  Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose

• Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol

  Cmax is the maximum observed analyte concentration.

  Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Ethinylestradiol

  The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

  Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Ethinylestradiol

  The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

  Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose

Secondary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Approximately 4 Months

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: Drospirenone/ethinylestradiol; Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)

Interventions

Drospirenone/ethinylestradiol DRUG

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

Also known as: Yaz®

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

AL-335 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.

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

Odalasvir (ODV) 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.

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

Simeprevir (SMV) DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

drospirenone; Ethinyl Estradiol; drospirenone and ethinyl estradiol combination; adafosbuvir; odalasvir; Simeprevir

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: August 31, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

US (1)