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A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females

NCT03126097 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-09-01

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the effect of single and multiple doses of JNJ-64155806 on the steady-state pharmacokinetics (PK) of ethinylestradiol and drospirenone and vice versa in healthy female participants.

Conditions

  • Healthy

Interventions

DRUG

JNJ-64155806 150 mg

JNJ-64155806 150 mg (3\*50 mg tablet) twice daily will be administered under fed conditions on Days 1 to 7 \[JNJ-64155806 Alone Phase\] and on Days 60 to 66 \[JNJ-64155806 + COCP Coadministration Phase\].

DRUG

Ethinylestradiol/drospirenone 0.02 mg/3 mg

Each tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol administered as combined oral contraceptive pill (COCP) given on Days 18 to 41 (lead-in phase), Days 46 to 69 (coadministration phase - Days 59 to 66 under fed conditions).

DRUG

COCP Placebo

Participant will receive COCP placebo tablets once daily on Days 42 to 45 (lead-in phase) and Days 70 to 73 (JNJ-64155806 + COCP coadministration phase).

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
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-04-13
Primary Completion
2017-05-26
Completion
2017-05-26
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 NCT03126097 on ClinicalTrials.gov