HealthyPhase 1NCT03249402
A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants
A Phase 1 study testing Ethinyl Estradiol + Levonorgestrel and JNJ-42847922 in people with Healthy, run by Janssen-Cilag International NV at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy female adult partcipants. 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?
- Ethinyl Estradiol + Levonorgestrel and JNJ-42847922
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Aug 2017to 24 Nov 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
- Be female of childbearing potential (women with tubal ligation are not accepted)
- Have a body weight equal to or over 45 kilogram (kg) and a body mass index (BMI) 23 within the range of 18 to 30 kilogram / square meter (kg/m^2) inclusive
- Have a systolic blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive, and diastolic blood pressure no higher than 90 mmHg
- Agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last dose of study drug
- Have a negative serum pregnancy test at screening and a negative predose urine pregnancy test on Day1 and Day 21 of Cycle 1 and Cycle 2
Who cannot join
- Participant has a past history of heart arrhythmias (extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
- Participant is currently pregnant or planning to become pregnant or lactating (from screening through at least 8 weeks after receiving the last dose of study drug)
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for HBsAg or hepatitis C virus antibody at screening.
- Participant has a history of or present allergy to the oral contraceptive (OC) or JNJ-42847922, or drugs of these classes, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- Participant has a history of alcohol/drug abuse or dependence within 12 months of the study: history of regular alcohol consumption averaging greater than (>) 14 drinks/week for women within 6 months of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Drug-drug Interaction Study in Healthy Female Adult Subjects to Investigate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel
The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy female adult partcipants.
- Conditions
- Healthy
- Being tested
- Ethinyl Estradiol + Levonorgestrel, JNJ-42847922
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinyl Estradiol + LevonorgestrelDrug
Also called Microgynon 30
Participants will receive one OC tablet containing EE 0.03 mg and LN 0.15 mg once daily on Days 1 to 21 in cycles 1 and 2.
JNJ-42847922Drug
Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2.
| Study group | Role | What they receive |
|---|---|---|
| Oral Contraceptive Tablet + JNJ-42847922 | Experimental | All participants will receive one oral contraceptive (OC) tablet containing ethinyl estradiol (EE) 0.03 milligram (mg) and levonorgestrel (LN) 0.15 mg once daily on Days 1 to 21 for both cycle 1 and cycle 2. In addition, in cycle 2, participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21. Participants will not be given OC tablet on Days 22 to 28 during cycle 1 and cycle 2 (tablet-free period). Receives: Drug: Ethinyl Estradiol + Levonorgestrel; Drug: JNJ-42847922 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) in Cycle 1
The Cmax is the maximum observed plasma concentration.
Measured: Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose
Maximum Observed Plasma Concentration (Cmax) in Cycle 2
The Cmax is the maximum observed plasma concentration.
Measured: Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose
Trough Plasma Concentration (Ctrough) in Cycle 1
The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.
Measured: Cycle1: Predose (Day 21)
Trough Plasma Concentration (Ctrough) in Cycle 2
The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.
Measured: Cycle 2: Predose (Day 21)
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 1
The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
Measured: Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 2
The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
Measured: Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose
Secondary outcomes (1)
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: Up to 87 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start14 Aug 2017
- Primary completion24 Nov 2017
- Study completion24 Nov 2017
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249402
- Sponsor's protocol ID
- CR108351
- Other IDs
- 2016-004725-16, 42847922MDD1003, 2016
- Status last verified
- Apr 2025
- First submitted
- 11 Aug 2017
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Drug-drug Interaction Study in Healthy Female Adult Subjects to Investigate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel
- ClinicalTrials.gov ID
- NCT03249402
- Acronym / sponsor ID
- CR108351
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 24 Nov 2017 (actual)
- First posted
- 15 Aug 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 purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy female adult partcipants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Contraceptive Tablet + JNJ-42847922 | Experimental | Drug: Ethinyl Estradiol + Levonorgestrel, Drug: JNJ-42847922All participants will receive one oral contraceptive (OC) tablet containing ethinyl estradiol (EE) 0.03 milligram (mg) and levonorgestrel (LN) 0.15 mg once daily on Days 1 to 21 for both cycle 1 and cycle 2. In addition, in cycle 2, participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21. Participants will not be given OC tablet on Days 22 to 28 during cycle 1 and cycle 2 (tablet-free period). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be female of childbearing potential (women with tubal ligation are not accepted)
- Have a body weight equal to or over 45 kilogram (kg) and a body mass index (BMI) 23 within the range of 18 to 30 kilogram / square meter (kg/m^2) inclusive
- Have a systolic blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive, and diastolic blood pressure no higher than 90 mmHg
- Agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last dose of study drug
- Have a negative serum pregnancy test at screening and a negative predose urine pregnancy test on Day1 and Day 21 of Cycle 1 and Cycle 2
Key exclusion criteria (5 listed)
- Participant has a past history of heart arrhythmias (extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
- Participant is currently pregnant or planning to become pregnant or lactating (from screening through at least 8 weeks after receiving the last dose of study drug)
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for HBsAg or hepatitis C virus antibody at screening.
- Participant has a history of or present allergy to the oral contraceptive (OC) or JNJ-42847922, or drugs of these classes, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- Participant has a history of alcohol/drug abuse or dependence within 12 months of the study: history of regular alcohol consumption averaging greater than (>) 14 drinks/week for women within 6 months of screening
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 |
|---|---|---|
| Ethinyl Estradiol + LevonorgestrelAlso: Microgynon 30Participants will receive one OC tablet containing EE 0.03 mg and LN 0.15 mg once daily on Days 1 to 21 in cycles 1 and 2. | Drug | Oral Contraceptive Tablet + JNJ-42847922 |
| JNJ-42847922Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2. | Drug | Oral Contraceptive Tablet + JNJ-42847922 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) in Cycle 1
Time frame: Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose
The Cmax is the maximum observed plasma concentration.
Maximum Observed Plasma Concentration (Cmax) in Cycle 2
Time frame: Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose
The Cmax is the maximum observed plasma concentration.
Trough Plasma Concentration (Ctrough) in Cycle 1
Time frame: Cycle1: Predose (Day 21)
The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.
Trough Plasma Concentration (Ctrough) in Cycle 2
Time frame: Cycle 2: Predose (Day 21)
The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 1
Time frame: Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose
The AUC (0-24) 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[0-24]) at Cycle 2
Time frame: Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose
The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
1 secondary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 87 Days
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 27 Apr 2025.
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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-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
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 Ethinyl Estradiol + Levonorgestrel and JNJ-42847922 in people with Healthy, run by Janssen-Cilag International NV 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 27 Apr 2025. 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?
Maximum Observed Plasma Concentration (Cmax) in Cycle 1 (time frame: Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose). The study lists 6 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 27 Apr 2025.