HealthyPhase 1NCT03126097
A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females
A Phase 1 study testing JNJ-64155806 150 mg and Ethinylestradiol/drospirenone 0.02 mg/3 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-64155806 150 mg and Ethinylestradiol/drospirenone 0.02 mg/3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2017to 26 May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- JNJ-64155806 150 mg, Ethinylestradiol/drospirenone 0.02 mg/3 mg, COCP Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64155806 150 mgDrug
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 mgDrug
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 PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| JNJ-64155806+COCP+JNJ-64155806 with COCP | Experimental | 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]. Receives: Drug: JNJ-64155806 150 mg; Drug: Ethinylestradiol/drospirenone 0.02 mg/3 mg; Drug: COCP Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough Plasma Concentration (Ctrough) for Ethinylestradiol
The Ctrough is the plasma concentration before dosing.
Measured: Days 57, 58, 59, 60, 66
Trough Plasma Concentration (Ctrough) for Drospirenone
The Ctrough is the plasma concentration before dosing.
Measured: Days 57, 58, 59, 60, 66
Minimum Observed Plasma Concentration (Cmin) for Ethinylestradiol
The Cmin is the minimum observed plasma concentration.
Measured: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
Minimum Observed Plasma Concentration (Cmin) for Drospirenone
The Cmin is the minimum observed plasma concentration.
Measured: 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
The Cmax is the maximum observed plasma concentration.
Measured: 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 Drospirenone
The Cmax is the maximum observed plasma concentration.
Measured: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Ethinylestradiol
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Drospirenone
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose
Average Plasma Concentration (C24h) at 24hours for Ethinylestradiol
C24h is observed analyte concentration at 24 hours.
Measured: Days 59, 60, 66
Average Plasma Concentration (C24h) at 24hours for Drospirenone
C24h is observed analyte concentration at 24 hours.
Measured: Days 59, 60, 66
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].
Measured: Days 59, 60, 66
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].
Measured: Days 59, 60, 66
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.
Measured: Days 59, 60, 66
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.
Measured: Days 59, 60, 66
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).
Measured: Days 59, 60, 66
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).
Measured: Days 59, 60, 66
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).
Measured: Days 59, 60, 66
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).
Measured: Days 59, 60, 66
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).
Measured: Days 59, 60, 66
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).
Measured: Days 59, 60, 66
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).
Measured: Days 59, 60, 66
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).
Measured: Days 59, 60, 66
Secondary outcomes (9)
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.
Measured: From Signing of Informed Consent Form (ICF) till End of Study (Day 73)
Minimum Observed Plasma Concentration (Cmin) for JNJ-64155806
The Cmin is the minimum observed plasma concentration.
Measured: Days 1, 7, 60, 66
Maximum Observed Plasma (Cmax) for JNJ-64155806
The Cmax is the maximum observed plasma concentration.
Measured: Days 1, 7, 60, 66
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.
Measured: Days 1, 7, 60, 66
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.
Measured: Days 1, 7, 60, 66
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.
Measured: Days 1, 7, 60, 66
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.
Measured: Days 5, 6, 7, 64, 65, 66
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].
Measured: Days 7 and 66
Fluctuation Index (FI) for JNJ-64155806
FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state).
Measured: Days 7 and 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start13 Apr 2017
- Primary completion26 May 2017
- Study completion26 May 2017
Why it stopped: Study stopping rules were met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126097
- Sponsor's protocol ID
- CR108266
- Other IDs
- 64155806FLZ1001
- Status last verified
- Aug 2017
- First submitted
- 13 Apr 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Drug-drug Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone
- ClinicalTrials.gov ID
- NCT03126097
- Acronym / sponsor ID
- CR108266
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopping rules were met.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-64155806+COCP+JNJ-64155806 with COCP | Experimental | Drug: JNJ-64155806 150 mg, Drug: Ethinylestradiol/drospirenone 0.02 mg/3 mg, Drug: COCP PlaceboParticipants 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]. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-64155806 150 mgJNJ-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 | JNJ-64155806+COCP+JNJ-64155806 with COCP |
| Ethinylestradiol/drospirenone 0.02 mg/3 mgEach 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 | JNJ-64155806+COCP+JNJ-64155806 with COCP |
| COCP PlaceboParticipant 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). | Drug | JNJ-64155806+COCP+JNJ-64155806 with COCP |
Primary outcome
Trough Plasma Concentration (Ctrough) for Ethinylestradiol
Time frame: Days 57, 58, 59, 60, 66
The Ctrough is the plasma concentration before dosing.
Trough Plasma Concentration (Ctrough) for Drospirenone
Time frame: Days 57, 58, 59, 60, 66
The Ctrough is the plasma concentration before dosing.
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
The Cmin is the minimum observed plasma concentration.
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
The Cmin is the minimum observed plasma concentration.
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
The Cmax is the maximum observed plasma concentration.
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
The Cmax is the maximum observed plasma concentration.
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
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Average Plasma Concentration (C24h) at 24hours for Ethinylestradiol
Time frame: Days 59, 60, 66
C24h is observed analyte concentration at 24 hours.
Average Plasma Concentration (C24h) at 24hours for Drospirenone
Time frame: Days 59, 60, 66
C24h is observed analyte concentration at 24 hours.
Average Plasma Concentration (Cavg) for Ethinylestradiol
Time frame: Days 59, 60, 66
Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval].
Average Plasma Concentration (Cavg) for Drospirenone
Time frame: Days 59, 60, 66
Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval].
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24h]) for Ethinylestradiol
Time frame: Days 59, 60, 66
The AUC(0-24h) is the area under the plasma concentration time curve from time zero to 24 hours.
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24h]) for Drospirenone
Time frame: Days 59, 60, 66
The AUC(0-24h) is the area under the plasma concentration time curve from time zero to 24 hours.
Fluctuation Index (FI) for Ethinylestradiol
Time frame: Days 59, 60, 66
FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).
Fluctuation Index (FI) for Drospirenone
Time frame: Days 59, 60, 66
FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).
Ratio of Cmin Values Between Test and Reference (Ratio Cmin,test/ref) for Ethinylestradiol
Time frame: Days 59, 60, 66
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).
Ratio of Cmin Values Between Test and Reference (Ratio Cmin,test/ref) for Drospirenone
Time frame: Days 59, 60, 66
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).
Ratio of Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) for Ethinylestradiol
Time frame: Days 59, 60, 66
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).
Ratio of Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) for Drospirenone
Time frame: Days 59, 60, 66
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).
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).
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).
9 secondary outcomes
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)
Minimum Observed Plasma Concentration (Cmin) for JNJ-64155806
Time frame: Days 1, 7, 60, 66
Maximum Observed Plasma (Cmax) for JNJ-64155806
Time frame: Days 1, 7, 60, 66
Time to Reach Maximum Observed Plasma Concentration (Tmax) for JNJ-64155806
Time frame: Days 1, 7, 60, 66
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
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
Trough Plasma Concentration (Ctrough) for JNJ-64155806
Time frame: Days 5, 6, 7, 64, 65, 66
Average Analyte Concentration (Cavg) for JNJ-64155806
Time frame: Days 7 and 66
Fluctuation Index (FI) for JNJ-64155806
Time frame: Days 7 and 66
Results and safety
The study was stopped early (reason given: Study stopping rules were met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-64155806 150 mg and Ethinylestradiol/drospirenone 0.02 mg/3 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study stopping rules were met.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough Plasma Concentration (Ctrough) for Ethinylestradiol (time frame: Days 57, 58, 59, 60, 66). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.