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

Janssen (J&J Innovative Medicine)

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-64530440; Drug: Midazolam; Drug: Drospirenone/Ethinylestradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03890341

JNJ-0440-1302 (Other Identifier)

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Drospirenone/Ethinylestradiol + Midazolam + JNJ-64530440

Experimental group

Description:

Participants will receive single oral dose of drospirenone/ethinylestradiol 3 milligram (mg)/0.02 mg (oral contraceptive \[OC\]) and midazolam 2 mg with under fed conditions (high fat meal) on Day 1 followed by JNJ-64530440 2,000 mg on Days 6 under fasted conditions ; JNJ-64530440 2,000 mg plus single oral dose of OC and midazolam 2 mg under fed conditions on Day 13; JNJ-64530440 2,000 mg once daily under fed conditions (standard meal) from Days 14 to 18; single oral dose of JNJ-64530440 2,000 mg plus single oral dose of OC and midazolam 2 mg on Day 19 under fed conditions (high fat meal); and JNJ-64530440 2,000 mg once daily under fed conditions (standard meal) on Days 20 to 22.

Treatment:

Drug: Drospirenone/Ethinylestradiol

Drug: JNJ-64530440

Drug: Midazolam