PharmacokineticsPhase 1NCT00915668
A Study to Evaluate the Pharmacokinetic Drug Interaction Between Multiple Doses of JNJ-31001074 and a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Women
A Phase 1 study testing JNJ-31001074 in people with Pharmacokinetics and Drug Interactions, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The main purpose of this research study is to evaluate the effect of multiple doses of an investigational drug known as JNJ-31001074 on the single dose of combination oral contraceptive Ovral-L containing ethinyl estradiol and levonorgestrel in healthy women who cannot bear children. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Drug Interactions, Healthy
- What is being tested?
- JNJ-31001074
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Mar 2011
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women of non-child bearing potential (i.e., postmenopausal [no spontaneous menses for at least 2 years] or surgically sterile) 18 to 65 years of age, inclusive
- negative pregnancy test
- body mass index between 18 and 30
- body weight greater than or equal to 50 kilograms
Who cannot join
- History of or current clinically significant medical illness
- abnormal lab values or physical exams
- pregnant or lactating
- used any hormonal products 3 months before study
- drug or alcohol abuse
- history of smoking or nicotine use, 2 weeks before start of study
- clinically significant allergy
- use of prescription and non-prescription medications within 2 weeks before the start of the study
About this study
Official title: An Open-Label, Randomized, Crossover Drug-Drug Interaction Study to Assess the Effects of Multiple Doses of JNJ-31001074 on the Pharmacokinetics of a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel
The main purpose of this research study is to evaluate the effect of multiple doses of an investigational drug known as JNJ-31001074 on the single dose of combination oral contraceptive Ovral-L containing ethinyl estradiol and levonorgestrel in healthy women who cannot bear children. This study will look at the safety, tolerability (how the drug makes you feel) and pharmacokinetics (what your body does to the drug) of either drug alone and in combination in healthy women.
Read the detailed description
This is an open-label (both the physician and patient know which treatment will be administered), single center randomized, drug-drug interaction study in healthy female volunteers of non-child bearing potential. A total of 32 volunteers will be enrolled. The study consists of a screening phase, an open label treatment period, and end of study/early withdrawal assessments. Volunteers will be randomly assigned to 1 of 2 treatment sequences. The open-label treatment phase will consist of two periods. In each period, volunteers will receive either of the following treatment(s): Treatment A: a single dose of oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel (Ovral-L) on Day 1 and Treatment B: multiple daily doses of 10 mg JNJ-31001074 on Days 1 to 8 and a single dose of oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel (Ovral-L) on Day 7. A washout (no treatment break or drug holiday) period of 28 days separates the two occasions of single dose administration of oral contraceptives in Periods 1 and 2. Safety and tolerability will be assessed from the time of informed consent to the end-of-study evaluations or early withdrawal. Volunteers will be instructed to report any serious adverse events that occur up to 30 days following the last dose of study drugs. For Treatment A, the volunteer will receive a single dose of oral contraceptive. For Treatment B, the volunteer will receive 10 mg tablet of JNJ-31001074 once daily orally for eight days (Days 1 to 8) and a single dose of oral contraceptive on Day 7.
- Conditions
- Pharmacokinetics, Drug Interactions, Healthy
- Being tested
- JNJ-31001074
- Keywords
- Healthy women, Non-childbearing potential, Drug-drug interaction, Oral contraceptive, OC, Ovral-L, ethinyl estradiol, EE, levonorgestrel, JNJ-31001074
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-31001074Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-dose pharmacokinetics of a combination oral contraceptive when given in combination with JNJ-31001074.
Measured: Blood samples taken over a period of 48 hours after combination treatment
Secondary outcomes (3)
To assess the multiple-dose pharmacokinetics of JNJ-31001074 in female volunteers
Measured: over a period of 9 days
To assess the safety and tolerability of multiple doses of JNJ-31001074 while administered alone
Measured: over a period of 6 days
To assess the safety and tolerability of multiple doses of JNJ-31001074 while administered together with a single-dose of an oral contraceptive in healthy female volunteers
Measured: over a period of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: The trial is postponed pending the completion of other ongoing pre-clinical and clinical work.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915668
- Sponsor's protocol ID
- CR016261
- Status last verified
- Nov 2010
- First submitted
- 4 Jun 2009
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Crossover Drug-Drug Interaction Study to Assess the Effects of Multiple Doses of JNJ-31001074 on the Pharmacokinetics of a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel
- ClinicalTrials.gov ID
- NCT00915668
- Acronym / sponsor ID
- CR016261
- Conditions
- Pharmacokinetics, Drug Interactions, Healthy
- Keywords
- Healthy women, Non-childbearing potential, Drug-drug interaction, Oral contraceptive, OC, Ovral-L, ethinyl estradiol, EE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial is postponed pending the completion of other ongoing pre-clinical and clinical work.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study completion
- Mar 2011 (estimated)
- First posted
- 8 Jun 2009 (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 main purpose of this research study is to evaluate the effect of multiple doses of an investigational drug known as JNJ-31001074 on the single dose of combination oral contraceptive Ovral-L containing ethinyl estradiol and levonorgestrel in healthy women who cannot bear children. This study will look at the safety, tolerability (how the drug makes you feel) and pharmacokinetics (what your body does to the drug) of either drug alone and in combination in healthy women.
Detailed description
This is an open-label (both the physician and patient know which treatment will be administered), single center randomized, drug-drug interaction study in healthy female volunteers of non-child bearing potential. A total of 32 volunteers will be enrolled. The study consists of a screening phase, an open label treatment period, and end of study/early withdrawal assessments. Volunteers will be randomly assigned to 1 of 2 treatment sequences. The open-label treatment phase will consist of two periods. In each period, volunteers will receive either of the following treatment(s): Treatment A: a single dose of oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel (Ovral-L) on Day 1 and Treatment B: multiple daily doses of 10 mg JNJ-31001074 on Days 1 to 8 and a single dose of oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel (Ovral-L) on Day 7. A washout (no treatment break or drug holiday) period of 28 days separates the two occasions of single dose administration of oral contraceptives in Periods 1 and 2. Safety and tolerability will be assessed from the time of informed consent to the end-of-study evaluations or early withdrawal. Volunteers will be instructed to report any serious adverse events that occur up to 30 days following the last dose of study drugs. For Treatment A, the volunteer will receive a single dose of oral contraceptive. For Treatment B, the volunteer will receive 10 mg tablet of JNJ-31001074 once daily orally for eight days (Days 1 to 8) and a single dose of oral contraceptive on Day 7.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women of non-child bearing potential (i.e., postmenopausal [no spontaneous menses for at least 2 years] or surgically sterile) 18 to 65 years of age, inclusive
- negative pregnancy test
- body mass index between 18 and 30
- body weight greater than or equal to 50 kilograms
Key exclusion criteria (8 listed)
- History of or current clinically significant medical illness
- abnormal lab values or physical exams
- pregnant or lactating
- used any hormonal products 3 months before study
- drug or alcohol abuse
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-31001074 | Drug | – |
Primary outcome
Single-dose pharmacokinetics of a combination oral contraceptive when given in combination with JNJ-31001074.
Time frame: Blood samples taken over a period of 48 hours after combination treatment
3 secondary outcomes
To assess the multiple-dose pharmacokinetics of JNJ-31001074 in female volunteers
Time frame: over a period of 9 days
To assess the safety and tolerability of multiple doses of JNJ-31001074 while administered alone
Time frame: over a period of 6 days
To assess the safety and tolerability of multiple doses of JNJ-31001074 while administered together with a single-dose of an oral contraceptive in healthy female volunteers
Time frame: over a period of 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
Related trials for Pharmacokinetics
Active, not recruitingPhase 2
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
RecruitingPhase 2
EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
PIK3CA-related Overgrowth Spectrum (PROS)
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Active, not recruitingPhase 1
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Not yet recruitingPhase 2
A Phase 2 Trial to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tegacorat in Male Participants 4 to <7 Years of Age With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy (DMD)
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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-31001074 in people with Pharmacokinetics and Drug Interactions, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Single-dose pharmacokinetics of a combination oral contraceptive when given in combination with JNJ-31001074. (time frame: Blood samples taken over a period of 48 hours after combination treatment). 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 20 Sep 2016.