Clinical trial NCT03890341: Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440
Official title: A Study in Healthy Female Participants to Investigate the Effect of JNJ-64530440 on the Single-dose of Ethinylestradiol and Drospirenone (Oral Contraceptive), and Midazolam, and the Effect of a High-fat Meal on the Single-dose of JNJ-64530440
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-03-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect of JNJ-64530440 single- and multiple-dose administration on the single-dose pharmacokinetics of drospirenone and ethinylestradiol (oral contraceptive) in healthy female participants.


Eligibility criteria: Inclusion Criteria:

* Must have a body mass index between 18.0 and 30.0 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kilogram (kg)
* Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the Investigator
* Must have a negative highly sensitive urine pregnancy test at Day -1 (all participants)
* Must have a negative highly sensitive serum beta-human chorionic gonadotropin pregnancy test at screening (all participants except for postmenopausal participants)
* Must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after the last study drug administration

Exclusion Criteria:

* Any evidence of heart block or bundle branch block
* History of liver or renal dysfunction (estimated creatinine clearance less than \[\<\] 90 milliliter per minute (mL/min) at screening, calculated by the Modification of Diet in Renal Disease (MDRD) formula), significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
* Past history of clinically significant cardiac arrhythmias (example \[eg\], premature ventricular contractions, premature atrial contractions, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
* Current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
* Current hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or Hepatitis B Virus (HBV) infection (confirmed by Hepatitis B surface antigen \[HBsAg\]), or Hepatitis C Virus (HCV) infection (confirmed by HCV antibody), or hepatitis E virus infection (confirmed by hepatitis E antibody IgM) at screening

Primary outcomes:
measure: Maximum Observed Plasma Analyte Concentration (Cmax) of Drospirenone
timeFrame: Days 1, 13, and 19: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 hours postdose
measure: Area Under the Plasma Analyte Concentration-Time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0-Last]) of Drospirenone
timeFrame: Days 1, 13, and 19: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 hours postdose
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of Drospirenone
timeFrame: Days 1, 13, and 19: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 hours postdose
measure: Maximum Observed Plasma Analyte Concentration (Cmax) of Ethinylestradiol
timeFrame: Days 1, 13, and 19: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 hours postdose
measure: Area Under the Plasma Analyte Concentration-Time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0-Last]) of Ethinylestradiol
timeFrame: Days 1, 13, and 19: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 hours postdose
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of Ethinylestradiol
timeFrame: Days 1, 13, and 19: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 hours postdose
Secondary outcomes:
measure: Maximum Observed Plasma Analyte Concentration (Cmax) of Midazolam
timeFrame: Days 1, 13, and 19: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Area Under the Plasma Analyte Concentration-Time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0-Last]) of Midazolam
timeFrame: Days 1, 13, and 19: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of Midazolam
timeFrame: Days 1, 13, and 19: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Cmax of JNJ-64530440 Under Fed Conditions (High-Fat Meal)
timeFrame: Days 13 and 19: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18 and 24 hours)
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-64530440
timeFrame: Days 13 and19: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18 and 24 hours
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Approximately up to 70 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: