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: | Not yet recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 3/28/2019 |
Start Date: | March 25, 2019 |
End Date: | June 30, 2019 |
Contact: | Study Contact |
Email: | JNJ.CT@sylogent.com |
Phone: | 844-434-4210 |
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
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.
administration on the single-dose pharmacokinetics of drospirenone and ethinylestradiol (oral
contraceptive) in healthy female participants.
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
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