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

NCT ID: NCT03126097

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-13
• Study Completion Date: 2017-05-26

Brief Summary

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.

Conditions

Healthy

Study Design

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

Study Groups

JNJ-64155806+COCP+JNJ-64155806 with COCP

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 \[JNJ-64155806 + COCP Co-administration Phase\].

Group Type: EXPERIMENTAL

JNJ-64155806 150 mg

Intervention Type: DRUG

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 mg

Intervention Type: DRUG

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 Placebo

Intervention Type: DRUG

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).

Interventions

JNJ-64155806 150 mg

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 \[JNJ-64155806 + COCP Coadministration Phase\].

Intervention Type: DRUG

Ethinylestradiol/drospirenone 0.02 mg/3 mg

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).

Intervention Type: DRUG

COCP Placebo

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).

Intervention Type: DRUG

Eligibility Criteria

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

• 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

Celerion

Tempe, Arizona, United States

Countries

United States

Other Identifiers

64155806FLZ1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108266

Identifier Type: -

Identifier Source: org_study_id