- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03126097
A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females
August 31, 2017 updated by: Janssen Research & Development, LLC
A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Drug-drug Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tempe, Arizona, United States, 85283
- Celerion
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Participant must be female of childbearing potential with a normal menstrual cycle, not using oral contraceptives in the 30 days prior to screening
- Participant must have a body mass index (BMI; weight in kilogram (kg) divided by the square of height in meters [m]) of 18.0 to 30.0 kg/m^2, extremes included, and a body weight not less than (<) 50.0 kg
- Participant must be willing and able to adhere to the requirements, instructions, and prohibitions and restrictions specified in this protocol, and is likely to complete the study as planned
- Participant must be healthy on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening. If the results of the biochemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Participants must be willing to start ethinylestradiol/drospirenone contraception during the COCP lead-in and JNJ-64155806 + COCP coadministration phases
Exclusion Criteria:
- Participant is a woman who is pregnant as confirmed by a positive beta human chorionic gonadotropin (beta-hCG) laboratory test, or who was pregnant within 6 months prior to study start, or who is breast-feeding, or who is planning to become pregnant from signing of the informed consent form (ICF) until 90 days after the last dose of study drug
- Participant with creatinine clearance of less than (<) 90 milliliter per minute (mL/min) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation)
- Participant with a clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic (syncope or seizures), thyroid, or any other medical illness or psychiatric disorder, as determined by the investigator and/or sponsor's medical monitor
- Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being), or that could prevent, limit, or confound the protocol-specified assessments
- Participant with currently active gynecological disorders including, but not limited to, vaginal bleeding without an obvious reason and hyperprolactinemia with or without galactorrhea
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: JNJ-64155806+COCP+JNJ-64155806 with COCP
Participants will receive JNJ-64155806 150 milligram (mg) twice daily (BID) under fed conditions on Days 1 to 7 [JNJ-64155806 Alone Phase] followed by a 10-day washout phase; followed by Ethinylestradiol/drospirenone 0.02 mg/3 mg given as a combined oral contraceptive pill (COCP) once daily (QD) on Days 18 to 41 and COCP placebo QD on Days 42 to 45 [COCP Lead-in Phase]; further followed by COCP QD on Days 46 to 69 (on Days 59 to 66 under fed condition), JNJ-64155806 150 mg BID (under fed conditions) on Days 60 to 66, and COCP placebo QD on Days 70 to 73 [JNJ-64155806 + COCP Co-administration Phase].
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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].
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).
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trough Plasma Concentration (Ctrough) for Ethinylestradiol
Time Frame: Days 57, 58, 59, 60, 66
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The Ctrough is the plasma concentration before dosing.
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Days 57, 58, 59, 60, 66
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Trough Plasma Concentration (Ctrough) for Drospirenone
Time Frame: Days 57, 58, 59, 60, 66
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The Ctrough is the plasma concentration before dosing.
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Days 57, 58, 59, 60, 66
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Minimum Observed Plasma Concentration (Cmin) for Ethinylestradiol
Time Frame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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The Cmin is the minimum observed plasma concentration.
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Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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Minimum Observed Plasma Concentration (Cmin) for Drospirenone
Time Frame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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The Cmin is the minimum observed plasma concentration.
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Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
|
Maximum Observed Plasma Concentration (Cmax) for Ethinylestradiol
Time Frame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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The Cmax is the maximum observed plasma concentration.
|
Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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Maximum Observed Plasma Concentration (Cmax) for Drospirenone
Time Frame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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The Cmax is the maximum observed plasma concentration.
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Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for Ethinylestradiol
Time Frame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for Drospirenone
Time Frame: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
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Average Plasma Concentration (C24h) at 24hours for Ethinylestradiol
Time Frame: Days 59, 60, 66
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C24h is observed analyte concentration at 24 hours.
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Days 59, 60, 66
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Average Plasma Concentration (C24h) at 24hours for Drospirenone
Time Frame: Days 59, 60, 66
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C24h is observed analyte concentration at 24 hours.
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Days 59, 60, 66
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Average Plasma Concentration (Cavg) for Ethinylestradiol
Time Frame: Days 59, 60, 66
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Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval].
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Days 59, 60, 66
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Average Plasma Concentration (Cavg) for Drospirenone
Time Frame: Days 59, 60, 66
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Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval].
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Days 59, 60, 66
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Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24h]) for Ethinylestradiol
Time Frame: Days 59, 60, 66
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The AUC(0-24h) is the area under the plasma concentration time curve from time zero to 24 hours.
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Days 59, 60, 66
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Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24h]) for Drospirenone
Time Frame: Days 59, 60, 66
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The AUC(0-24h) is the area under the plasma concentration time curve from time zero to 24 hours.
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Days 59, 60, 66
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Fluctuation Index (FI) for Ethinylestradiol
Time Frame: Days 59, 60, 66
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FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).
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Days 59, 60, 66
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Fluctuation Index (FI) for Drospirenone
Time Frame: Days 59, 60, 66
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FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).
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Days 59, 60, 66
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Ratio of Cmin Values Between Test and Reference (Ratio Cmin,test/ref) for Ethinylestradiol
Time Frame: Days 59, 60, 66
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Ratio Cmin,test/ref is the ratio of individual Cmin values between test and reference treatment.
Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone).
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Days 59, 60, 66
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Ratio of Cmin Values Between Test and Reference (Ratio Cmin,test/ref) for Drospirenone
Time Frame: Days 59, 60, 66
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Ratio Cmin,test/ref is the ratio of individual Cmin values between test and reference treatment.
Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone).
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Days 59, 60, 66
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Ratio of Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) for Ethinylestradiol
Time Frame: Days 59, 60, 66
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Ratio Cmax,test/ref is the ratio of individual Cmax values between test and reference treatment.
Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone).
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Days 59, 60, 66
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Ratio of Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) for Drospirenone
Time Frame: Days 59, 60, 66
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Ratio Cmax,test/ref is the ratio of individual Cmax values between test and reference treatment.
Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone).
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Days 59, 60, 66
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Ratio of AUC(0-24h) Values Between Test and Reference (Ratio AUC[0-24h],test/ref) for Ethinylestradiol
Time Frame: Days 59, 60, 66
|
Ratio AUC(0-24h),test/ref is the ratio of individual AUC(0-24h) values between test and reference treatment.
Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone).
|
Days 59, 60, 66
|
Ratio of AUC(0-24h) Values Between Test and Reference Treatment (Ratio AUC[0-24h],test/ref) for Drospirenone
Time Frame: Days 59, 60, 66
|
Ratio AUC(0-24h),test/ref is the ratio of individual AUC(0-24h) values between test and reference treatment.
Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone).
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Days 59, 60, 66
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: From Signing of Informed Consent Form (ICF) till End of Study (Day 73)
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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From Signing of Informed Consent Form (ICF) till End of Study (Day 73)
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Minimum Observed Plasma Concentration (Cmin) for JNJ-64155806
Time Frame: Days 1, 7, 60, 66
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The Cmin is the minimum observed plasma concentration.
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Days 1, 7, 60, 66
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Maximum Observed Plasma (Cmax) for JNJ-64155806
Time Frame: Days 1, 7, 60, 66
|
The Cmax is the maximum observed plasma concentration.
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Days 1, 7, 60, 66
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for JNJ-64155806
Time Frame: Days 1, 7, 60, 66
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The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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Days 1, 7, 60, 66
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Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12h]) for JNJ-64155806
Time Frame: Days 1, 7, 60, 66
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The AUC(0-12h) is the area under the plasma concentration time curve from time zero to 12 hours.
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Days 1, 7, 60, 66
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Area Under the Plasma Concentration-time Curve From 12 Hours to 24 Hours (AUC[12-24h]) for JNJ-64155806
Time Frame: Days 1, 7, 60, 66
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The AUC(12h-24h) is the area under the plasma concentration time curve from time 12 hours to 24 hours.
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Days 1, 7, 60, 66
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Trough Plasma Concentration (Ctrough) for JNJ-64155806
Time Frame: Days 5, 6, 7, 64, 65, 66
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Ctrough is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
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Days 5, 6, 7, 64, 65, 66
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Average Analyte Concentration (Cavg) for JNJ-64155806
Time Frame: Days 7 and 66
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Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval].
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Days 7 and 66
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Fluctuation Index (FI) for JNJ-64155806
Time Frame: Days 7 and 66
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FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state).
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Days 7 and 66
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 13, 2017
Primary Completion (ACTUAL)
May 26, 2017
Study Completion (ACTUAL)
May 26, 2017
Study Registration Dates
First Submitted
April 13, 2017
First Submitted That Met QC Criteria
April 21, 2017
First Posted (ACTUAL)
April 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 1, 2017
Last Update Submitted That Met QC Criteria
August 31, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Natriuretic Agents
- Diuretics
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Hormonal
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Ethinyl Estradiol
- Drospirenone
- Drospirenone and ethinyl estradiol combination
Other Study ID Numbers
- CR108266
- 64155806FLZ1001 (OTHER: Janssen Research & Development, LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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