HealthyPhase 1NCT00915746
A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers
A Phase 1 study testing JNJ-31001074; ketoconazole in people with Healthy and Pharmacokinetics, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
This is an open-label (both the physician and healthy volunteer know which treatment will be administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken alone and in combination with ketoconazole. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokinetics, Drug Interactions
- What is being tested?
- JNJ-31001074; ketoconazole
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Dec 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer between the ages of 18-55
- if a woman, must be of non childbearing potential (ie, post menopausal or surgically sterile) and have a negative pregnancy test
- body mass index between 18-30
- body weight greater than or equal to 50 kilograms
- blood pressure between 90 and 140 mgHg systolic and no higher than 90 mgHg diastolic
- nonsmoker
Who cannot join
- History of or current clinically significant medical illness
- clinically significant abnormal laboratory value(s)
- clinically significant abnormal physical examination, vital signs or electrocardiogram
- pregnant, lactating or completed last term pregnancy within six months of screening
- use of any prescription or non prescription medication except for paracetamol (acetaminophen/TYLENOL), bisphosphonates (drugs to treat osteoporosis), hormone replacement therapy within 14 days of first dose of study medication
- history of drug or alcohol abuse
- history of smoking or use of nicotine-containing substances within the previous two months
About this study
Official title: An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of JNJ-31001074 in Healthy Subjects
This is an open-label (both the physician and healthy volunteer know which treatment will be administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken alone and in combination with ketoconazole. The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase consisting of three periods and an end-of study/early withdrawal assessment phase.
Read the detailed description
This is an open-label (both the physician and healthy volunteer know which treatment will be administered), sequential design (one after the other) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken alone and in combination with ketoconazole. The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase consisting of three periods and an end-of-study/early withdrawal assessment phase. During the screening phase, healthy volunteers will be evaluated to see if they meet selection criteria as specified in the protocol. Healthy volunteers who meet these criteria will report to the study center on Day -1. Volunteers will be admitted to the study center and will fast (no food or beverages) overnight for at least 10 hours. Volunteers will remain at the study center for 11 days. The open-label treatment phase consists of three periods. In Period 1, a single-dose of JNJ-31001074 10 mg will be administered on Day 1, followed by three days of multiple blood sampling (Days 1-3). In Period 2 (Days 4-6), 400 mg ketoconazole will be administered on each day just prior to which predose blood samples are taken. In Period 3 (Days 7-11), JNJ-31001074 10 mg and ketoconazole 400 mg will be administered together on Day 7, followed by four days of multiple blood sampling. Ketoconazole will also be administered on Day 8 and Day 9 of Period 3. No study drug will be administered on Days 2 and 3 of Period 1, and Days 10 and 11 of Period 3. The end-of-study phase assessments will be performed after the completion of the four day blood sampling on Day 11. Safety and tolerability will be assessed throughout the volunteer's participation. Volunteers will be instructed to report any adverse events that occur up to 30 days after their last dose of study drug. The maximum study duration for each volunteer is expected to be 32 days. JNJ-31001074 10 mg will be administered orally on Days 1 and 7; ketoconazole 400 mg will be administered orally on Days 4, 5, 6, 7, 8, and 9.
- Conditions
- Healthy, Pharmacokinetics, Drug Interactions
- Being tested
- JNJ-31001074; ketoconazole
- Keywords
- Phase I, ketoconazole, CYP3A4 inhibitor, drug interaction, metabolism, Healthly Volunteer, JNJ-31001074
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-31001074; ketoconazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to assess the effects of repeated daily administration of 400 mg of ketoconazole on the single-dose pharmacokinetics of JNJ-31001074 in healthy volunteers
Measured: Multiple blood samples will be obtained over the 11 day open-label treatment phase
Secondary outcomes (1)
To assess the safety and tolerability of JNJ-31001074 with and without coadministration of ketoconazole
Measured: up to 32 days (including a 21 day screening phase)
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 startNov 2009
- Study completionDec 2009
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT00915746
- Sponsor's protocol ID
- CR016342
- Status last verified
- Apr 2010
- First submitted
- 4 Jun 2009
- Last updated
- 30 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of JNJ-31001074 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00915746
- Acronym / sponsor ID
- CR016342
- Conditions
- Healthy, Pharmacokinetics, Drug Interactions
- Keywords
- Phase I, ketoconazole, CYP3A4 inhibitor, drug interaction, metabolism, Healthly Volunteer, JNJ-31001074
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Study completion
- Dec 2009 (actual)
- 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.
This is an open-label (both the physician and healthy volunteer know which treatment will be administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken alone and in combination with ketoconazole. The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase consisting of three periods and an end-of study/early withdrawal assessment phase.
Detailed description
This is an open-label (both the physician and healthy volunteer know which treatment will be administered), sequential design (one after the other) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken alone and in combination with ketoconazole. The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase consisting of three periods and an end-of-study/early withdrawal assessment phase. During the screening phase, healthy volunteers will be evaluated to see if they meet selection criteria as specified in the protocol. Healthy volunteers who meet these criteria will report to the study center on Day -1. Volunteers will be admitted to the study center and will fast (no food or beverages) overnight for at least 10 hours. Volunteers will remain at the study center for 11 days. The open-label treatment phase consists of three periods. In Period 1, a single-dose of JNJ-31001074 10 mg will be administered on Day 1, followed by three days of multiple blood sampling (Days 1-3). In Period 2 (Days 4-6), 400 mg ketoconazole will be administered on each day just prior to which predose blood samples are taken. In Period 3 (Days 7-11), JNJ-31001074 10 mg and ketoconazole 400 mg will be administered together on Day 7, followed by four days of multiple blood sampling. Ketoconazole will also be administered on Day 8 and Day 9 of Period 3. No study drug will be administered on Days 2 and 3 of Period 1, and Days 10 and 11 of Period 3. The end-of-study phase assessments will be performed after the completion of the four day blood sampling on Day 11. Safety and tolerability will be assessed throughout the volunteer's participation. Volunteers will be instructed to report any adverse events that occur up to 30 days after their last dose of study drug. The maximum study duration for each volunteer is expected to be 32 days. JNJ-31001074 10 mg will be administered orally on Days 1 and 7; ketoconazole 400 mg will be administered orally on Days 4, 5, 6, 7, 8, and 9.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy volunteer between the ages of 18-55
- if a woman, must be of non childbearing potential (ie, post menopausal or surgically sterile) and have a negative pregnancy test
- body mass index between 18-30
- body weight greater than or equal to 50 kilograms
- blood pressure between 90 and 140 mgHg systolic and no higher than 90 mgHg diastolic
Key exclusion criteria (7 listed)
- History of or current clinically significant medical illness
- clinically significant abnormal laboratory value(s)
- clinically significant abnormal physical examination, vital signs or electrocardiogram
- pregnant, lactating or completed last term pregnancy within six months of screening
- use of any prescription or non prescription medication except for paracetamol (acetaminophen/TYLENOL), bisphosphonates (drugs to treat osteoporosis), hormone replacement therapy within 14 days of first dose of study medication
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; ketoconazole | Drug | – |
Primary outcome
The primary objective is to assess the effects of repeated daily administration of 400 mg of ketoconazole on the single-dose pharmacokinetics of JNJ-31001074 in healthy volunteers
Time frame: Multiple blood samples will be obtained over the 11 day open-label treatment phase
1 secondary outcome
To assess the safety and tolerability of JNJ-31001074 with and without coadministration of ketoconazole
Time frame: up to 32 days (including a 21 day screening phase)
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 30 Apr 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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; ketoconazole in people with Healthy and Pharmacokinetics, 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 6 inclusion and 7 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 30 Apr 2010. 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 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?
The primary objective is to assess the effects of repeated daily administration of 400 mg of ketoconazole on the single-dose pharmacokinetics of JNJ-31001074 in healthy volunteers (time frame: Multiple blood samples will be obtained over the 11 day open-label treatment phase). 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 30 Apr 2010.