A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females
Status: | Terminated |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 9/2/2017 |
Start Date: | April 13, 2017 |
End Date: | May 26, 2017 |
A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Drug-drug Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone
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.
JNJ-64155806 on the steady-state pharmacokinetics (PK) of ethinylestradiol and drospirenone
and vice versa in healthy female participants.
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
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