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

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: COCP Placebo; Drug: JNJ-64155806 150 mg; Drug: Ethinylestradiol/drospirenone 0.02 mg/3 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03126097

64155806FLZ1001 (Other Identifier)

CR108266

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

JNJ-64155806+COCP+JNJ-64155806 with COCP

Experimental group

Description:

Participants will receive JNJ-64155806 150 milligram (mg) twice daily (BID) under fed conditions on Days 1 to 7 \[JNJ-64155806 Alone Phase\] followed by a 10-day washout phase; followed by Ethinylestradiol/drospirenone 0.02 mg/3 mg given as a combined oral contraceptive pill (COCP) once daily (QD) on Days 18 to 41 and COCP placebo QD on Days 42 to 45 \[COCP Lead-in Phase\]; further followed by COCP QD on Days 46 to 69 (on Days 59 to 66 under fed condition), JNJ-64155806 150 mg BID (under fed conditions) on Days 60 to 66, and COCP placebo QD on Days 70 to 73 \[JNJ-64155806 + COCP Co-administration Phase\].

Treatment:

Drug: Ethinylestradiol/drospirenone 0.02 mg/3 mg

Drug: JNJ-64155806 150 mg

Drug: COCP Placebo