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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03890341
• Other study ID #: JNJ-0440-1302
• Secondary ID: JNJ-0440-1302
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: March 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Drospirenone/Ethinylestradiol
A single oral dose of drospirenone/ethinylestradiol 3 mg/0.02 mg (OC) tablets will be administered on Days 1, 13 and 19.
• Midazolam
Midazolam 2 mg will be administered orally on Days 1, 13 and 19.
• JNJ-64530440
A single oral dose of JNJ-64530440 2,000 mg will be administered on Day 6 and once daily on Days 13 to 22.

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Analyte Concentration (Cmax) of Drospirenone	Cmax is defined as maximum observed plasma analyte concentration.	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
Primary	Area Under the Plasma Analyte Concentration-Time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0-Last]) of Drospirenone	AUC(0-Last) is area under the plasma analyte concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.	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
Primary	Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of Drospirenone	AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-below quantification limit) concentration.	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
Primary	Maximum Observed Plasma Analyte Concentration (Cmax) of Ethinylestradiol	Cmax is defined as maximum observed plasma analyte concentration.	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
Primary	Area Under the Plasma Analyte Concentration-Time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0-Last]) of Ethinylestradiol	AUC(0-Last) is area under the plasma analyte concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.	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
Primary	Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of Ethinylestradiol	AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-below quantification limit) concentration.	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	Maximum Observed Plasma Analyte Concentration (Cmax) of Midazolam	The Cmax is the maximum observed plasma analyte concentration.	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
Secondary	Area Under the Plasma Analyte Concentration-Time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0-Last]) of Midazolam	AUC(0-Last) is area under the plasma analyte concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.	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
Secondary	Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of Midazolam	AUC(0-Last) is area under the plasma concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.	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
Secondary	Cmax of JNJ-64530440 Under Fed Conditions (High-Fat Meal)	Cmax is defined as the maximum observed plasma concentration. Cmax will be assessed under fed conditions (high-fat meal).	Days 13 and 19: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18 and 24 hours)
Secondary	Maximum Observed Plasma Concentration (Cmax) of JNJ-64530440	The Cmax is the maximum observed plasma analyte concentration.	Days 13 and19: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18 and 24 hours
Secondary	Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment.	Approximately up to 70 days