HealthyPhase 1NCT02661893
A Drug Interaction Study in Healthy Participants to Assess the Effect of Rifampin on the Pharmacokinetics of JNJ-42847922
A Phase 1 study testing JNJ-42847922 and Rifampin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of single- and multiple-dose of rifampin on the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-42847922 and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Feb 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women of non-child-bearing potential between 18 and 60 years of age, inclusive; body mass index (BMI) between 18 and 30 kilogram (kg)/meter^2, inclusive, and body weight of not less than 50 kg who are nonsmokers (current and for past 60 days)
Who cannot join
- History of or current clinically significant medical illness
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis
- Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG)
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled until completion of the study
- Received a known inhibitor of cytochrome P450 (CYP) 3A4 or CYP2C9 activity within 28 days or a period less than 5 times the drugs half-life; whichever is longer, before the first dose of the study drug is scheduled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Drug Interaction Study to Assess the Pharmacokinetics of JNJ-42847922 When Administered Alone and in Combination With Rifampin in Healthy Male and Female Subjects
The purpose of this study is to assess the effect of single- and multiple-dose of rifampin on the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy male and female participants.
Read the detailed description
This is an open-label, fixed-sequence, single-center, multiple-dose study in 14 healthy adults. All participants will receive a single oral dose of 40 milligram (mg) JNJ-42847922 on 3 separate occasions: Day 1 (JNJ-42847922 alone), Day 5 (JNJ-42847922 with a single dose of rifampin), and Day 12 (JNJ-42847922 in combination with steady-state rifampin). A daily dose of 600 mg (2 * 300 mg) rifampin will be administered from Day 5 through Day 12. Following JNJ-42847922 dosing, serial blood samples will be collected over 48 hours for the evaluation of plasma concentrations of JNJ-42847922 and its metabolites. Participants' safety will be monitored throughout the study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42847922Drug
A single oral dose of 40 milligram (mg) (=2*20 mg) dose of JNJ42847922 on Day 1, Day 5 and Day 12.
RifampinDrug
Oral dose of rifampin 600 mg (2*300 mg) on Day 5 and once daily dosing of rifampin with an oral dose of rifampin 600 mg (2*300 mg) on Days 5 to 12.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-42847922 and Rifampin | Experimental | A single oral dose of 40 milligram (mg) (=2*20 mg) dose of JNJ-42847922 on Day 1; A single oral dose of 40 mg (=2*20 mg) dose of JNJ-42847922 dosed with one oral dose of rifampin 600 mg (2*300 mg) on Day 5; A single oral dose of 40 mg (=2*20 mg) dose of JNJ-42847922 dosed on Day 12, following once daily dosing of rifampin with an oral dose of rifampin 600 mg (2*300 mg) on Days 5-12. Receives: Drug: JNJ-42847922; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 1
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Measured: Day 1
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 5
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Measured: Day 5
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 12
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Measured: Day 12
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 1
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Measured: Day 1
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 5
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Measured: Day 5
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 12
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Measured: Day 12
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: up to Day 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionFeb 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT02661893
- Sponsor's protocol ID
- CR108077
- Other IDs
- 42847922EDI1009
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Drug Interaction Study to Assess the Pharmacokinetics of JNJ-42847922 When Administered Alone and in Combination With Rifampin in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02661893
- Acronym / sponsor ID
- CR108077
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-42847922, Rifampin, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 25 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 assess the effect of single- and multiple-dose of rifampin on the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy male and female participants.
Detailed description
This is an open-label, fixed-sequence, single-center, multiple-dose study in 14 healthy adults. All participants will receive a single oral dose of 40 milligram (mg) JNJ-42847922 on 3 separate occasions: Day 1 (JNJ-42847922 alone), Day 5 (JNJ-42847922 with a single dose of rifampin), and Day 12 (JNJ-42847922 in combination with steady-state rifampin). A daily dose of 600 mg (2 * 300 mg) rifampin will be administered from Day 5 through Day 12. Following JNJ-42847922 dosing, serial blood samples will be collected over 48 hours for the evaluation of plasma concentrations of JNJ-42847922 and its metabolites. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-42847922 and Rifampin | Experimental | Drug: JNJ-42847922, Drug: RifampinA single oral dose of 40 milligram (mg) (=2*20 mg) dose of JNJ-42847922 on Day 1; A single oral dose of 40 mg (=2*20 mg) dose of JNJ-42847922 dosed with one oral dose of rifampin 600 mg (2*300 mg) on Day 5; A single oral dose of 40 mg (=2*20 mg) dose of JNJ-42847922 dosed on Day 12, following once daily dosing of rifampin with an oral dose of rifampin 600 mg (2*300 mg) on Days 5-12. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women of non-child-bearing potential between 18 and 60 years of age, inclusive; body mass index (BMI) between 18 and 30 kilogram (kg)/meter^2, inclusive, and body weight of not less than 50 kg who are nonsmokers (current and for past 60 days)
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis
- Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG)
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled until completion of the study
- Received a known inhibitor of cytochrome P450 (CYP) 3A4 or CYP2C9 activity within 28 days or a period less than 5 times the drugs half-life; whichever is longer, before the first dose of the study drug is scheduled
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-42847922A single oral dose of 40 milligram (mg) (=2*20 mg) dose of JNJ42847922 on Day 1, Day 5 and Day 12. | Drug | JNJ-42847922 and Rifampin |
| RifampinOral dose of rifampin 600 mg (2*300 mg) on Day 5 and once daily dosing of rifampin with an oral dose of rifampin 600 mg (2*300 mg) on Days 5 to 12. | Drug | JNJ-42847922 and Rifampin |
Primary outcome
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 1
Time frame: Day 1
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 5
Time frame: Day 5
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 12
Time frame: Day 12
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 1
Time frame: Day 1
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 5
Time frame: Day 5
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 12
Time frame: Day 12
Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.
1 secondary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to Day 44
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 3 Feb 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 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-42847922 and Rifampin 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 1 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 3 Feb 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 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 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?
Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 1 (time frame: Day 1). 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 3 Feb 2025.