A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females

Phase 1TerminatedNCT03126097

Janssen Research & Development, LLC18 enrolled

Overview

The primary purpose of this study is to evaluate the effect of single and multiple doses of JNJ-64155806 on the steady-state pharmacokinetics (PK) of ethinylestradiol and drospirenone and vice versa in healthy female participants.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

JNJ-64155806 150 mgDRUG

JNJ-64155806 150 mg (3\*50 mg tablet) twice daily will be administered under fed conditions on Days 1 to 7 \[JNJ-64155806 Alone Phase\] and on Days 60 to 66 \[JNJ-64155806 + COCP Coadministration Phase\].

Ethinylestradiol/drospirenone 0.02 mg/3 mgDRUG

Each tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol administered as combined oral contraceptive pill (COCP) given on Days 18 to 41 (lead-in phase), Days 46 to 69 (coadministration phase - Days 59 to 66 under fed conditions).

COCP PlaceboDRUG

Participant will receive COCP placebo tablets once daily on Days 42 to 45 (lead-in phase) and Days 70 to 73 (JNJ-64155806 + COCP coadministration phase).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participant must be female of childbearing potential with a normal menstrual cycle, not using oral contraceptives in the 30 days prior to screening * Participant must have a body mass index (BMI; weight in kilogram (kg) divided by the square of height in meters \[m\]) of 18.0 to 30.0 kg/m\^2, extremes included, and a body weight not less than (\<) 50.0 kg * Participant must be willing and able to adhere to the requirements, instructions, and prohibitions and restrictions specified in this protocol, and is likely to complete the study as planned * Participant must be healthy on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening. If the results of the biochemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator * Participants must be willing to start ethinylestradiol/drospirenone contraception during the COCP lead-in and JNJ-64155806 + COCP coadministration phases Exclusion Criteria: * Participant is a woman who is pregnant as confirmed by a positive beta human chorionic gonadotropin (beta-hCG) laboratory test, or who was pregnant within 6 months prior to study start, or who is breast-feeding, or who is planning to become pregnant from signing of the informed consent form (ICF) until 90 days after the last dose of study drug * Participant with creatinine clearance of less than (\<) 90 milliliter per minute (mL/min) (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation) * Participant with a clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic (syncope or seizures), thyroid, or any other medical illness or psychiatric disorder, as determined by the investigator and/or sponsor's medical monitor * Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being), or that could prevent, limit, or confound the protocol-specified assessments * Participant with currently active gynecological disorders including, but not limited to, vaginal bleeding without an obvious reason and hyperprolactinemia with or without galactorrhea

Locations (1)

Celerion

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Trough Plasma Concentration (Ctrough) for Ethinylestradiol

The Ctrough is the plasma concentration before dosing.

Time frame: Days 57, 58, 59, 60, 66

Trough Plasma Concentration (Ctrough) for Drospirenone

The Ctrough is the plasma concentration before dosing.

Time frame: Days 57, 58, 59, 60, 66

Minimum Observed Plasma Concentration (Cmin) for Ethinylestradiol

The Cmin is the minimum observed plasma concentration.