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

• Status: Withdrawn
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Betadex; Contraceptive Agents; Contraceptives, Oral; Drospirenone; Drospirenone and ethinyl estradiol combination; Ethinyl Estradiol; Midazolam

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