HealthyPhase 1NCT01631487
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants
A Phase 1 study testing JNJ-39439335 10 mg, JNJ-39439335 25 mg and JNJ-39439335 50 mg 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 investigate the safety, tolerability, and pharmacokinetics of JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in healthy Japanese adult male participants in Part 2. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-39439335 10 mg, JNJ-39439335 25 mg and JNJ-39439335 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2013
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese or Caucasian participants
- Nonsmoker
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive, and body weight not less than 50 kg
- Healthy on the basis of a physical examination, vital signs, hematology, coagulation, serum chemistry (including liver function tests) and urinalysis
- Willing to adhere to the prohibitions and restrictions specified by the study protocol
Who cannot join
- Oral temperatures > 37.5 Celsius degrees
- Participants who have occupations or hobbies in which they are routinely exposed to situations in which they could sustain thermal burns
- Abnormal electrocardiogram (ECG) results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Sequential Group, Single Ascending and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Subjects
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in healthy Japanese adult male participants in Part 2.
Read the detailed description
This is a double-blind (neither physician nor participant knows the treatment that the participant receives), randomized (the study drug is assigned by chance), placebo-controlled study (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial). The study consists of 2 Parts. In Part 1, three groups of healthy Japanese men and 3 groups of healthy Caucasian men will receive a single oral dose of JNJ-39439335 or placebo on Day 1. Each group will include 8 participants. The study duration of Part 1 for each participant is approximately 8 weeks: screening phase of up to 28 days prior to dose, treatment phase of 14 days, and a follow-up phase of 14 to16 days. In Part 2, three groups of healthy Japanese men will receive once-daily doses of either JNJ-39439335 or placebo for 21 days. Each group will include 12 participants. The study duration of Part 2 for each participant is approximately 11 weeks: screening phase of up to 28 days prior to dose, treatment phase of 21 days, and a follow-up phase of approximately 28 days. During the treatment phases, the participants will remain in the study unit. Blood samples and urine will be collected for drug concentration measurements and laboratory safety assessments.
- Conditions
- Healthy
- Being tested
- JNJ-39439335 10 mg, JNJ-39439335 25 mg, JNJ-39439335 50 mg, Placebo
- Keywords
- Healthy, JNJ-39439335, Japanese, Caucasian, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-39439335 10 mgDrug
Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.
JNJ-39439335 25 mgDrug
Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.
JNJ-39439335 50 mgDrug
Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.
PlaceboDrug
Multiple (once daily for 21 days) oral doses of matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Japanese Group 1: JNJ-39439335/placebo (Part 1) | Experimental | Not described Receives: Drug: JNJ-39439335 10 mg; Drug: Placebo |
| Japanese Group 2: JNJ-39439335/placebo (Part 1) | Experimental | Not described Receives: Drug: JNJ-39439335 25 mg; Drug: Placebo |
| Japanese Group 3: JNJ-39439335/placebo (Part 1) | Experimental | Not described Receives: Drug: JNJ-39439335 50 mg; Drug: Placebo |
| Caucasian Group 1: JNJ-39439335/placebo (Part 1) | Experimental | Not described Receives: Drug: JNJ-39439335 10 mg; Drug: Placebo |
| Caucasian Group 2: JNJ-39439335/placebo (Part 1) | Experimental | Not described Receives: Drug: JNJ-39439335 25 mg; Drug: Placebo |
| Caucasian Group 3: JNJ-39439335/placebo (Part 1) | Experimental | Not described Receives: Drug: JNJ-39439335 50 mg; Drug: Placebo |
| Japanese Group 1: JNJ-39439335/placebo (Part 2) | Experimental | Not described Receives: Drug: JNJ-39439335 10 mg; Drug: Placebo |
| Japanese Group 2: JNJ-39439335/placebo (Part 2) | Experimental | Not described Receives: Drug: JNJ-39439335 25 mg; Drug: Placebo |
| Japanese Group 3: JNJ-39439335/placebo (Part 2) | Experimental | Not described Receives: Drug: JNJ-39439335 50 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of JNJ-39439335 (Part 1)
Measured: up to 14 days
Urine concentrations of JNJ-39439335 (Part 1)
Measured: up to 5 days
Plasma concentrations of JNJ-39439335 (Part 2)
Measured: up to 21 days
Urine concentrations of JNJ-39439335 (Part 2)
Measured: up to 21 days
Secondary outcomes (2)
Incidence of Adverse Events (Part 1)
Measured: Approximately 8 weeks
Incidence of Adverse Events (Part 2)
Measured: Approximately 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2013
- Study completionMar 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 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
- NCT01631487
- Sponsor's protocol ID
- CR100890
- Other IDs
- 39439335PAI1005
- Status last verified
- Jun 2013
- First submitted
- 27 Jun 2012
- Last updated
- 25 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Sequential Group, Single Ascending and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01631487
- Acronym / sponsor ID
- CR100890
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-39439335, Japanese, Caucasian, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Jun 2012 (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 investigate the safety, tolerability, and pharmacokinetics of JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in healthy Japanese adult male participants in Part 2.
Detailed description
This is a double-blind (neither physician nor participant knows the treatment that the participant receives), randomized (the study drug is assigned by chance), placebo-controlled study (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial). The study consists of 2 Parts. In Part 1, three groups of healthy Japanese men and 3 groups of healthy Caucasian men will receive a single oral dose of JNJ-39439335 or placebo on Day 1. Each group will include 8 participants. The study duration of Part 1 for each participant is approximately 8 weeks: screening phase of up to 28 days prior to dose, treatment phase of 14 days, and a follow-up phase of 14 to16 days. In Part 2, three groups of healthy Japanese men will receive once-daily doses of either JNJ-39439335 or placebo for 21 days. Each group will include 12 participants. The study duration of Part 2 for each participant is approximately 11 weeks: screening phase of up to 28 days prior to dose, treatment phase of 21 days, and a follow-up phase of approximately 28 days. During the treatment phases, the participants will remain in the study unit. Blood samples and urine will be collected for drug concentration measurements and laboratory safety assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Japanese Group 1: JNJ-39439335/placebo (Part 1) | Experimental | Drug: JNJ-39439335 10 mg, Drug: Placebo |
| Japanese Group 2: JNJ-39439335/placebo (Part 1) | Experimental | Drug: JNJ-39439335 25 mg, Drug: Placebo |
| Japanese Group 3: JNJ-39439335/placebo (Part 1) | Experimental | Drug: JNJ-39439335 50 mg, Drug: Placebo |
| Caucasian Group 1: JNJ-39439335/placebo (Part 1) | Experimental | Drug: JNJ-39439335 10 mg, Drug: Placebo |
| Caucasian Group 2: JNJ-39439335/placebo (Part 1) | Experimental | Drug: JNJ-39439335 25 mg, Drug: Placebo |
| Caucasian Group 3: JNJ-39439335/placebo (Part 1) | Experimental | Drug: JNJ-39439335 50 mg, Drug: Placebo |
| Japanese Group 1: JNJ-39439335/placebo (Part 2) | Experimental | Drug: JNJ-39439335 10 mg, Drug: Placebo |
| Japanese Group 2: JNJ-39439335/placebo (Part 2) | Experimental | Drug: JNJ-39439335 25 mg, Drug: Placebo |
| Japanese Group 3: JNJ-39439335/placebo (Part 2) | Experimental | Drug: JNJ-39439335 50 mg, Drug: Placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Japanese or Caucasian participants
- Nonsmoker
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive, and body weight not less than 50 kg
- Healthy on the basis of a physical examination, vital signs, hematology, coagulation, serum chemistry (including liver function tests) and urinalysis
- Willing to adhere to the prohibitions and restrictions specified by the study protocol
Key exclusion criteria (5 listed)
- Oral temperatures > 37.5 Celsius degrees
- Participants who have occupations or hobbies in which they are routinely exposed to situations in which they could sustain thermal burns
- Abnormal electrocardiogram (ECG) results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
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-39439335 10 mgMultiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg. | Drug | Caucasian Group 1: JNJ-39439335/placebo (Part 1), Japanese Group 1: JNJ-39439335/placebo (Part 1), Japanese Group 1: JNJ-39439335/placebo (Part 2) |
| JNJ-39439335 25 mgMultiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg. | Drug | Caucasian Group 2: JNJ-39439335/placebo (Part 1), Japanese Group 2: JNJ-39439335/placebo (Part 1), Japanese Group 2: JNJ-39439335/placebo (Part 2) |
| JNJ-39439335 50 mgMultiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg. | Drug | Caucasian Group 3: JNJ-39439335/placebo (Part 1), Japanese Group 3: JNJ-39439335/placebo (Part 1), Japanese Group 3: JNJ-39439335/placebo (Part 2) |
| PlaceboMultiple (once daily for 21 days) oral doses of matching placebo. | Drug | Caucasian Group 1: JNJ-39439335/placebo (Part 1), Caucasian Group 2: JNJ-39439335/placebo (Part 1), Caucasian Group 3: JNJ-39439335/placebo (Part 1), Japanese Group 1: JNJ-39439335/placebo (Part 1), Japanese Group 1: JNJ-39439335/placebo (Part 2), Japanese Group 2: JNJ-39439335/placebo (Part 1), Japanese Group 2: JNJ-39439335/placebo (Part 2), Japanese Group 3: JNJ-39439335/placebo (Part 1), Japanese Group 3: JNJ-39439335/placebo (Part 2) |
Primary outcome
Plasma concentrations of JNJ-39439335 (Part 1)
Time frame: up to 14 days
Urine concentrations of JNJ-39439335 (Part 1)
Time frame: up to 5 days
Plasma concentrations of JNJ-39439335 (Part 2)
Time frame: up to 21 days
Urine concentrations of JNJ-39439335 (Part 2)
Time frame: up to 21 days
2 secondary outcomes
Incidence of Adverse Events (Part 1)
Time frame: Approximately 8 weeks
Incidence of Adverse Events (Part 2)
Time frame: Approximately 11 weeks
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 25 Jun 2013.
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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-39439335 10 mg, JNJ-39439335 25 mg and JNJ-39439335 50 mg 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 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 25 Jun 2013. 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?
Plasma concentrations of JNJ-39439335 (Part 1) (time frame: up to 14 days). The study lists 4 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 25 Jun 2013.