Clinical trial NCT03126097: A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females
Official title: A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Drug-drug Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Trough Plasma Concentration (Ctrough) for Ethinylestradiol
timeFrame: Days 57, 58, 59, 60, 66
measure: Trough Plasma Concentration (Ctrough) for Drospirenone
timeFrame: Days 57, 58, 59, 60, 66
measure: Minimum Observed Plasma Concentration (Cmin) for Ethinylestradiol
timeFrame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
measure: Minimum Observed Plasma Concentration (Cmin) for Drospirenone
timeFrame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
measure: Maximum Observed Plasma Concentration (Cmax) for Ethinylestradiol
timeFrame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
measure: Maximum Observed Plasma Concentration (Cmax) for Drospirenone
timeFrame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for Ethinylestradiol
timeFrame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for Drospirenone
timeFrame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
measure: Average Plasma Concentration (C24h) at 24hours for Ethinylestradiol
timeFrame: Days 59, 60, 66
measure: Average Plasma Concentration (C24h) at 24hours for Drospirenone
timeFrame: Days 59, 60, 66
measure: Average Plasma Concentration (Cavg) for Ethinylestradiol
timeFrame: Days 59, 60, 66
measure: Average Plasma Concentration (Cavg) for Drospirenone
timeFrame: Days 59, 60, 66
measure: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24h]) for Ethinylestradiol
timeFrame: Days 59, 60, 66
measure: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24h]) for Drospirenone
timeFrame: Days 59, 60, 66
measure: Fluctuation Index (FI) for Ethinylestradiol
timeFrame: Days 59, 60, 66
measure: Fluctuation Index (FI) for Drospirenone
timeFrame: Days 59, 60, 66
measure: Ratio of Cmin Values Between Test and Reference (Ratio Cmin,test/ref) for Ethinylestradiol
timeFrame: Days 59, 60, 66
measure: Ratio of Cmin Values Between Test and Reference (Ratio Cmin,test/ref) for Drospirenone
timeFrame: Days 59, 60, 66
measure: Ratio of Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) for Ethinylestradiol
timeFrame: Days 59, 60, 66
measure: Ratio of Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) for Drospirenone
timeFrame: Days 59, 60, 66
measure: Ratio of AUC(0-24h) Values Between Test and Reference (Ratio AUC[0-24h],test/ref) for Ethinylestradiol
timeFrame: Days 59, 60, 66
measure: Ratio of AUC(0-24h) Values Between Test and Reference Treatment (Ratio AUC[0-24h],test/ref) for Drospirenone
timeFrame: Days 59, 60, 66
Secondary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: From Signing of Informed Consent Form (ICF) till End of Study (Day 73)
measure: Minimum Observed Plasma Concentration (Cmin) for JNJ-64155806
timeFrame: Days 1, 7, 60, 66
measure: Maximum Observed Plasma (Cmax) for JNJ-64155806
timeFrame: Days 1, 7, 60, 66
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for JNJ-64155806
timeFrame: Days 1, 7, 60, 66
measure: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12h]) for JNJ-64155806
timeFrame: Days 1, 7, 60, 66
measure: Area Under the Plasma Concentration-time Curve From 12 Hours to 24 Hours (AUC[12-24h]) for JNJ-64155806
timeFrame: Days 1, 7, 60, 66
measure: Trough Plasma Concentration (Ctrough) for JNJ-64155806
timeFrame: Days 5, 6, 7, 64, 65, 66
measure: Average Analyte Concentration (Cavg) for JNJ-64155806
timeFrame: Days 7 and 66
measure: Fluctuation Index (FI) for JNJ-64155806
timeFrame: Days 7 and 66
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: