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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

NCT03890341 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-03-26

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

DRUG

Midazolam

Midazolam 2 mg will be administered orally on Days 1, 13 and 19.

DRUG

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-08-01
Completion
2021-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03890341 on ClinicalTrials.gov