HealthyPhase 1NCT02652650
A Study to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone
A Phase 1 study testing Ethinylestradiol, Norethindrone and JNJ-63623872 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the effect of steady-state concentrations of JNJ-63623872 on the steady-state pharmacokinetics of ethinylestradiol and norethindrone 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?
- Ethinylestradiol, Norethindrone and JNJ-63623872
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2015to Jun 2016
- 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 willing and able to adhere to the prohibitions and restrictions specified in the protocol
- Participants must, if heterosexually active with a partner who is not vasectomized (confirmed sterile), be practicing an effective method of contraception before entry and agree to continue to use two effective methods of contraception throughout the study and for at least 30 days after receiving the last intake of oral contraceptive (OC) plus JNJ-63623872 on Day 77
- Participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 of Cycle I
- Participants must agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last intake of OC plus JNJ-63623872 on Day 77
- Participants must have a Body Mass Index (BMI); between 18.0 and 30.0 kilogram per square meter (kg/m^2) (extremes included)
Who cannot join
- Participant has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- At screening, participants with one or more of the laboratory abnormalities specified in the protocol as defined by the World Health Organization (WHO) Toxicity Grading Scale
- Participant with a past history of heart arrhythmias (extrasystole, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
- Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticarial
- Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
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 Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone
The purpose of this study is to evaluate the effect of steady-state concentrations of JNJ-63623872 on the steady-state pharmacokinetics of ethinylestradiol and norethindrone in healthy female participants.
Read the detailed description
This is a Phase 1 and open-label study. The study consists of Screening Phase (less than or equal to (<=) 28 days before Day 1), Treatment Phase (Day 1 up to Day 78) and Follow up Phase (10 to 14 days after last study drug intake or, if an adverse event occurs, 30 to 35 days after last study drug intake). Treatment phase will consist of three Oral Contraceptive (OC) cycles (each cycle consists of 21 days of ethinylestradiol/norethindrone followed by 7 pill-free days). The duration of the treatment phase, including the OC-free period of Cycles I and II, will be 78 days. Blood samples will be collected for measurement of pharmacokinetic (Pk) parameters. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Ethinylestradiol, Norethindrone, JNJ-63623872
- Keywords
- Healthy, JNJ-63623872, Ethinylestradiol, Norethindrone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthinylestradiolDrug
Participants will receive 35 microgram (mcg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in) during first OC cycle; Days 29 to 49 (Cycle II: OC alone, reference) during the second OC cycle and Days 57 to 77 during third OC cycle.
NorethindroneDrug
Participants will receive 1 milligram (mg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in) during first OC cycle; Days 29 to 49 (Cycle II: OC alone, reference) during the second OC cycle and Days 57 to 77 during third OC cycle.
JNJ-63623872Drug
Participants will receive 600 mg twice daily (bid) for 5 days on Days 73 to 77 (Cycle III: OC plus JNJ-63623872, test) during third OC cycle under fed conditions.
| Study group | Role | What they receive |
|---|---|---|
| Ethinylestradiol/Norethindrone | Experimental | During the first oral contraceptive (OC) cycle participants will receive ethinylestradiol/norethindrone 35 microgram (mcg)/1 milligram (mg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in). During the second OC cycle (from Day 29 to Day 56), participants will receive ethinylestradiol/norethindrone 35 mcg/1 mg alone qd for 21 days on Days 29 to 49 (Cycle II: OC alone, reference). During the third OC cycle (from Day 57 to Day 84), participants will receive ethinylestradiol/norethindrone 35 mcg/1 mg qd for 21 days on Days 57 to 77 and in addition JNJ-63623872, 600 mg twice daily (bid) for 5 days on Days 73 to 77 (Cycle III: OC plus JNJ-63623872, test). Receives: Drug: Ethinylestradiol; Drug: Norethindrone; Drug: JNJ-63623872 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Measured: Post-dose on Days 75 and 76 of Cycle III
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Observed Analyte Concentration at 12 Hours Post Dosing (C12h) of JNJ-63623872
C12h is the observed analyte concentration at 12 hours post dosing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Minimum Observed Analyte Concentration (Cmin) of JNJ-63623872
Cmin is the minimum observed analyte concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Maximum Observed Analyte Concentration (Cmax) of JNJ-63623872
Cmax is the maximum observed analyte concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Time To Reach The Maximum Observed Analyte Concentration (Tmax) of JNJ-63623872
Tmax is the actual sampling time to reach the maximum observed analyte concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Area Under the Analyte Concentration versus Time Curve (AUC) From Time of Administration up to 12 Hours Post Dosing (AUC12h) of JNJ-63623872
AUC12h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 12 hours post dosing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Average Steady-State Plasma Concentration (Cavg) of JNJ-63623872
Cavg is the average steady-state plasma concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Percentage Fluctuation (FI) of JNJ-63623872
FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied ([Cmax - Cmin] / Cavg).
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Ethinylestradiol
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Measured: Post-dose on Days 47 and 48 of Cycle II; post-dose on Days 75 and 76 of Cycle III
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Norethindrone
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Measured: Post-dose on Days 47 and 48 of Cycle II; post-dose on Days 75 and 76 of Cycle III
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Ethinylestradiol
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Norethindrone
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Observed Analyte Concentration at 24 Hours Post Dosing (C24h) of Ethinylestradiol
C24h is the observed analyte concentration at 24 hours post dosing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Observed Analyte Concentration at 24 Hours Post Dosing (C24h) of Norethindrone
C24h is the observed analyte concentration at 24 hours post dosing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Minimum Observed Analyte Concentration (Cmin) of Ethinylestradiol
Cmin is the minimum observed analyte concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Minimum Observed Analyte Concentration (Cmin) of Norethindrone
Cmin is the minimum observed analyte concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Maximum Observed Analyte Concentration (Cmax) of Ethinylestradiol
Cmax is the maximum observed analyte concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Maximum Observed Analyte Concentration (Cmax) of Norethindrone
Cmax is the maximum observed analyte concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Time To Reach The Maximum Observed Analyte Concentration (Tmax) of Ethinylestradiol
Tmax is the actual sampling time to reach the maximum observed analyte concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Time To Reach The Maximum Observed Analyte Concentration (Tmax) of Norethindrone
Tmax is the actual sampling time to reach the maximum observed analyte concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Area Under the Analyte Concentration versus Time Curve (auc) From Time of Administration up to 24 Hours Post Dosing (AUC24h) of Ethinylestradiol
AUC24h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Area Under the Analyte Concentration versus Time Curve (auc) From Time of Administration up to 24 Hours Post Dosing (AUC24h) of Norethindrone
AUC24h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Average Steady-State Plasma Concentration (Cavg) of Ethinylestradiol
Cavg average steady-state plasma concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Average Steady-State Plasma Concentration (Cavg) of Norethindrone
Cavg average steady-state plasma concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Percentage Fluctuation (FI) of Ethinylestradiol
FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied ([Cmax - Cmin] / Cavg).
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Percentage Fluctuation (FI) of Norethindrone
FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied ([Cmax - Cmin] / Cavg).
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Ratio of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax, test/ref) of Ethinylestradiol
Ratio Cmax, test/ref is the ratio of individual Cmax values between test and reference treatment of ethinylestradiol.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Ratio of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax, test/ref) of Norethindrone
Ratio Cmax, test/ref is the ratio of individual Cmax values between test and reference treatment of Norethindrone.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Ratio of Individual AUC24h Values Between Test and Reference Treatment (Ratio AUC24h, test/ref) of Ethinylestradiol
Ratio AUC24h, test/ref is the ratio of individual AUC24h values between test and reference treatment of Ethinylestradiol.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Ratio of Individual AUC24h Values Between Test and Reference Treatment (Ratio AUC24h, test/ref) of Norethindrone
Ratio AUC24h, test/ref is the ratio of individual AUC24h values between test and reference treatment of Norethindrone.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionJun 2016
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
- 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
- NCT02652650
- Sponsor's protocol ID
- CR108093
- Other IDs
- 63623872FLZ1009, 2015-000639-34, 2015
- Status last verified
- Jun 2016
- First submitted
- 8 Jan 2016
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. 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 Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone
- ClinicalTrials.gov ID
- NCT02652650
- Acronym / sponsor ID
- CR108093
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-63623872, Ethinylestradiol, Norethindrone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Jan 2016 (estimated)
- 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 purpose of this study is to evaluate the effect of steady-state concentrations of JNJ-63623872 on the steady-state pharmacokinetics of ethinylestradiol and norethindrone in healthy female participants.
Detailed description
This is a Phase 1 and open-label study. The study consists of Screening Phase (less than or equal to (<=) 28 days before Day 1), Treatment Phase (Day 1 up to Day 78) and Follow up Phase (10 to 14 days after last study drug intake or, if an adverse event occurs, 30 to 35 days after last study drug intake). Treatment phase will consist of three Oral Contraceptive (OC) cycles (each cycle consists of 21 days of ethinylestradiol/norethindrone followed by 7 pill-free days). The duration of the treatment phase, including the OC-free period of Cycles I and II, will be 78 days. Blood samples will be collected for measurement of pharmacokinetic (Pk) parameters. Participants' safety will be monitored throughout the study.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ethinylestradiol/Norethindrone | Experimental | Drug: Ethinylestradiol, Drug: Norethindrone, Drug: JNJ-63623872During the first oral contraceptive (OC) cycle participants will receive ethinylestradiol/norethindrone 35 microgram (mcg)/1 milligram (mg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in). During the second OC cycle (from Day 29 to Day 56), participants will receive ethinylestradiol/norethindrone 35 mcg/1 mg alone qd for 21 days on Days 29 to 49 (Cycle II: OC alone, reference). During the third OC cycle (from Day 57 to Day 84), participants will receive ethinylestradiol/norethindrone 35 mcg/1 mg qd for 21 days on Days 57 to 77 and in addition JNJ-63623872, 600 mg twice daily (bid) for 5 days on Days 73 to 77 (Cycle III: OC plus JNJ-63623872, test). |
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 willing and able to adhere to the prohibitions and restrictions specified in the protocol
- Participants must, if heterosexually active with a partner who is not vasectomized (confirmed sterile), be practicing an effective method of contraception before entry and agree to continue to use two effective methods of contraception throughout the study and for at least 30 days after receiving the last intake of oral contraceptive (OC) plus JNJ-63623872 on Day 77
- Participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 of Cycle I
- Participants must agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last intake of OC plus JNJ-63623872 on Day 77
- Participants must have a Body Mass Index (BMI); between 18.0 and 30.0 kilogram per square meter (kg/m^2) (extremes included)
Key exclusion criteria (5 listed)
- Participant has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- At screening, participants with one or more of the laboratory abnormalities specified in the protocol as defined by the World Health Organization (WHO) Toxicity Grading Scale
- Participant with a past history of heart arrhythmias (extrasystole, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
- Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticarial
- Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
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 |
|---|---|---|
| EthinylestradiolParticipants will receive 35 microgram (mcg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in) during first OC cycle; Days 29 to 49 (Cycle II: OC alone, reference) during the second OC cycle and Days 57 to 77 during third OC cycle. | Drug | Ethinylestradiol/Norethindrone |
| NorethindroneParticipants will receive 1 milligram (mg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in) during first OC cycle; Days 29 to 49 (Cycle II: OC alone, reference) during the second OC cycle and Days 57 to 77 during third OC cycle. | Drug | Ethinylestradiol/Norethindrone |
| JNJ-63623872Participants will receive 600 mg twice daily (bid) for 5 days on Days 73 to 77 (Cycle III: OC plus JNJ-63623872, test) during third OC cycle under fed conditions. | Drug | Ethinylestradiol/Norethindrone |
Primary outcome
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872
Time frame: Post-dose on Days 75 and 76 of Cycle III
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Observed Analyte Concentration at 12 Hours Post Dosing (C12h) of JNJ-63623872
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
C12h is the observed analyte concentration at 12 hours post dosing.
Minimum Observed Analyte Concentration (Cmin) of JNJ-63623872
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Cmin is the minimum observed analyte concentration.
Maximum Observed Analyte Concentration (Cmax) of JNJ-63623872
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Cmax is the maximum observed analyte concentration.
Time To Reach The Maximum Observed Analyte Concentration (Tmax) of JNJ-63623872
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Tmax is the actual sampling time to reach the maximum observed analyte concentration.
Area Under the Analyte Concentration versus Time Curve (AUC) From Time of Administration up to 12 Hours Post Dosing (AUC12h) of JNJ-63623872
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
AUC12h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 12 hours post dosing.
Average Steady-State Plasma Concentration (Cavg) of JNJ-63623872
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
Cavg is the average steady-state plasma concentration.
Percentage Fluctuation (FI) of JNJ-63623872
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II
FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied ([Cmax - Cmin] / Cavg).
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Ethinylestradiol
Time frame: Post-dose on Days 47 and 48 of Cycle II; post-dose on Days 75 and 76 of Cycle III
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Norethindrone
Time frame: Post-dose on Days 47 and 48 of Cycle II; post-dose on Days 75 and 76 of Cycle III
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Ethinylestradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Norethindrone
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Observed Analyte Concentration at 24 Hours Post Dosing (C24h) of Ethinylestradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
C24h is the observed analyte concentration at 24 hours post dosing.
Observed Analyte Concentration at 24 Hours Post Dosing (C24h) of Norethindrone
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
C24h is the observed analyte concentration at 24 hours post dosing.
Minimum Observed Analyte Concentration (Cmin) of Ethinylestradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Cmin is the minimum observed analyte concentration.
Minimum Observed Analyte Concentration (Cmin) of Norethindrone
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Cmin is the minimum observed analyte concentration.
Maximum Observed Analyte Concentration (Cmax) of Ethinylestradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Cmax is the maximum observed analyte concentration.
Maximum Observed Analyte Concentration (Cmax) of Norethindrone
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Cmax is the maximum observed analyte concentration.
Time To Reach The Maximum Observed Analyte Concentration (Tmax) of Ethinylestradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Tmax is the actual sampling time to reach the maximum observed analyte concentration.
Time To Reach The Maximum Observed Analyte Concentration (Tmax) of Norethindrone
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Tmax is the actual sampling time to reach the maximum observed analyte concentration.
Area Under the Analyte Concentration versus Time Curve (auc) From Time of Administration up to 24 Hours Post Dosing (AUC24h) of Ethinylestradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
AUC24h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.
Area Under the Analyte Concentration versus Time Curve (auc) From Time of Administration up to 24 Hours Post Dosing (AUC24h) of Norethindrone
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
AUC24h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.
Average Steady-State Plasma Concentration (Cavg) of Ethinylestradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Cavg average steady-state plasma concentration.
Average Steady-State Plasma Concentration (Cavg) of Norethindrone
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Cavg average steady-state plasma concentration.
Percentage Fluctuation (FI) of Ethinylestradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied ([Cmax - Cmin] / Cavg).
Percentage Fluctuation (FI) of Norethindrone
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied ([Cmax - Cmin] / Cavg).
Ratio of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax, test/ref) of Ethinylestradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Ratio Cmax, test/ref is the ratio of individual Cmax values between test and reference treatment of ethinylestradiol.
Ratio of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax, test/ref) of Norethindrone
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Ratio Cmax, test/ref is the ratio of individual Cmax values between test and reference treatment of Norethindrone.
Ratio of Individual AUC24h Values Between Test and Reference Treatment (Ratio AUC24h, test/ref) of Ethinylestradiol
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Ratio AUC24h, test/ref is the ratio of individual AUC24h values between test and reference treatment of Ethinylestradiol.
Ratio of Individual AUC24h Values Between Test and Reference Treatment (Ratio AUC24h, test/ref) of Norethindrone
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III
Ratio AUC24h, test/ref is the ratio of individual AUC24h values between test and reference treatment of Norethindrone.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
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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 Ethinylestradiol, Norethindrone and JNJ-63623872 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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: finished, as of the sponsor's last update on 6 Jun 2016. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872 (time frame: Post-dose on Days 75 and 76 of Cycle III). The study lists 31 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 6 Jun 2016.