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

Healthy Clinical Trial

Official title:

A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Drug-drug Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03126097
• Other study ID #: CR108266
• Secondary ID: 64155806FLZ1001
• Status: Terminated
• Phase: Phase 1
• First received: April 13, 2017
• Last updated: August 31, 2017
• Start date: April 13, 2017
• Est. completion date: May 26, 2017

Study information

• Verified date: August 2017
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: May 26, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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].
• 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).
• 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).

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

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	Trough Plasma Concentration (Ctrough) for Ethinylestradiol	The Ctrough is the plasma concentration before dosing.	Days 57, 58, 59, 60, 66
Primary	Trough Plasma Concentration (Ctrough) for Drospirenone	The Ctrough is the plasma concentration before dosing.	Days 57, 58, 59, 60, 66
Primary	Minimum Observed Plasma Concentration (Cmin) for Ethinylestradiol	The Cmin is the minimum observed plasma concentration.	Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
Primary	Minimum Observed Plasma Concentration (Cmin) for Drospirenone	The Cmin is the minimum observed plasma concentration.	Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
Primary	Maximum Observed Plasma Concentration (Cmax) for Ethinylestradiol	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
Primary	Maximum Observed Plasma Concentration (Cmax) for Drospirenone	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
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for Ethinylestradiol	The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.	Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for Drospirenone	The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.	Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
Primary	Average Plasma Concentration (C24h) at 24hours for Ethinylestradiol	C24h is observed analyte concentration at 24 hours.	Days 59, 60, 66
Primary	Average Plasma Concentration (C24h) at 24hours for Drospirenone	C24h is observed analyte concentration at 24 hours.	Days 59, 60, 66
Primary	Average Plasma Concentration (Cavg) for Ethinylestradiol	Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval].	Days 59, 60, 66
Primary	Average Plasma Concentration (Cavg) for Drospirenone	Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval].	Days 59, 60, 66
Primary	Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24h]) for Ethinylestradiol	The AUC(0-24h) is the area under the plasma concentration time curve from time zero to 24 hours.	Days 59, 60, 66
Primary	Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24h]) for Drospirenone	The AUC(0-24h) is the area under the plasma concentration time curve from time zero to 24 hours.	Days 59, 60, 66
Primary	Fluctuation Index (FI) for Ethinylestradiol	FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).	Days 59, 60, 66
Primary	Fluctuation Index (FI) for Drospirenone	FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).	Days 59, 60, 66
Primary	Ratio of Cmin Values Between Test and Reference (Ratio Cmin,test/ref) for Ethinylestradiol	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).	Days 59, 60, 66
Primary	Ratio of Cmin Values Between Test and Reference (Ratio Cmin,test/ref) for Drospirenone	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).	Days 59, 60, 66
Primary	Ratio of Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) for Ethinylestradiol	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).	Days 59, 60, 66
Primary	Ratio of Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) for Drospirenone	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).	Days 59, 60, 66
Primary	Ratio of AUC(0-24h) Values Between Test and Reference (Ratio AUC[0-24h],test/ref) for Ethinylestradiol	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
Primary	Ratio of AUC(0-24h) Values Between Test and Reference Treatment (Ratio AUC[0-24h],test/ref) for Drospirenone	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
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	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.	From Signing of Informed Consent Form (ICF) till End of Study (Day 73)
Secondary	Minimum Observed Plasma Concentration (Cmin) for JNJ-64155806	The Cmin is the minimum observed plasma concentration.	Days 1, 7, 60, 66
Secondary	Maximum Observed Plasma (Cmax) for JNJ-64155806	The Cmax is the maximum observed plasma concentration.	Days 1, 7, 60, 66
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for JNJ-64155806	The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.	Days 1, 7, 60, 66
Secondary	Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12h]) for JNJ-64155806	The AUC(0-12h) is the area under the plasma concentration time curve from time zero to 12 hours.	Days 1, 7, 60, 66
Secondary	Area Under the Plasma Concentration-time Curve From 12 Hours to 24 Hours (AUC[12-24h]) for JNJ-64155806	The AUC(12h-24h) is the area under the plasma concentration time curve from time 12 hours to 24 hours.	Days 1, 7, 60, 66
Secondary	Trough Plasma Concentration (Ctrough) for JNJ-64155806	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.	Days 5, 6, 7, 64, 65, 66
Secondary	Average Analyte Concentration (Cavg) for JNJ-64155806	Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval].	Days 7 and 66
Secondary	Fluctuation Index (FI) for JNJ-64155806	FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state).	Days 7 and 66