Healthy Male VolunteerPhase 1NCT01442532
A Study of the Safety and Pharmacokinetics of JNJ-38518168 in Japanese and Caucasian Male Participants and the Effect of JNJ-38518168 on the Blood Levels of Midazolam
A Phase 1 study testing JNJ-38518168 (30 mg), JNJ-38518168 (10 mg) and JNJ-38518168 (3 mg) in people with Healthy Male Volunteer, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of Part 1 of this study is to evaluate the safety, tolerability, and pharmacokinetics ("PK", how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of JNJ-38518168 in comparison with placebo following single dose and 14 days of consecutive dosing… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteer
- What is being tested?
- JNJ-38518168 (30 mg), JNJ-38518168 (10 mg) and JNJ-38518168 (3 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part 1 only:
- Male, 20 to 55 years of age.
- Be either:
- Of Japanese descent who has resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report. Japanese participants must have a valid Japanese passport.
- or
- A non-Hispanic Caucasian participant who has Caucasian parents as determined by participant's verbal report.
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- Have a body mass index (BMI) of 18.5 kg/m2 to 25 kg/m2 for participants of Japanese descent and between 18.5 kg/m2 and 30 kg/m2 for Caucasian participants.
- Have a body weight of not less than 50 kg.
- Part 2 only:
- Male, 18 to 55 years of age
- Have a BMI of 18.5 kg/m2 to 30 kg/m2 and have a body weight of not less than 50 kg.
- For both Parts 1 and 2:
- Be otherwise healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, coagulation and urinalysis, measurement of vital signs, and ECG. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judge the abnormalities or deviations from normal to be not clinically significant.
- If a man is heterosexually active with a woman of childbearing potential, he must be surgically sterile or agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.
- Have a blood pressure measurement between 90 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic, at screening.
- Have a 12-lead ECG consistent with normal cardiac conduction and function at screening.
- Non-smoker.
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
- History of hypersensitivity to or intolerance of midazolam (Part 2 only)
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or admission to the study center in Period 1 as deemed appropriate by the investigator.
- Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or admission to the study center in Period 1 as deemed appropriate by the investigator.
- Has any known malignancy or a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study drug).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Single- and Multiple-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38518168 in Japanese and Caucasian Healthy Adult Male Subjects and an Open-Label Drug-Drug Interaction Study to Evaluate the Effect of JNJ-38518168 on the Pharmacokinetics of Midazolam, a CYP3A4 Substrate
The purpose of Part 1 of this study is to evaluate the safety, tolerability, and pharmacokinetics ("PK", how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of JNJ-38518168 in comparison with placebo following single dose and 14 days of consecutive dosing in healthy Japanese and Caucasian adult male participants. Part 2 of this study will evaluate the effect of JNJ-38518168 on the pharmacokinetics of midazolam in healthy participants.
Read the detailed description
Participants will be assigned to either Part 1 or Part 2 of this study. Part 1 will be a single-center, double-blind (participants and study personnel will not know the identity of the treatments), randomized (treatment will be assigned by chance), single- and multiple-dose study. There will be 3 groups in Part 1, and the dosing will be as follows: Group A will receive a single oral dose of 30 mg JNJ-38518168 (given as three 10-mg tablets of JNJ-38518168) or placebo (a treatment identical in appearance to JNJ-38518168 but not containing active drug) (Period 1), and multiple oral doses of 30 mg JNJ 38518168 (given as three 10-mg tablets of JNJ-38518168) or matching placebo once daily for 14 consecutive days (Period 2); Group B will receive a single oral dose of 10 mg JNJ-38518168 or placebo (Period 1), and multiple oral doses of 10 mg JNJ-38518168 or placebo once daily for 14 consecutive days (Period 2); and Group C will receive a single oral dose of 3 mg JNJ-38518168 or placebo (Period 1), and multiple oral doses of 3 mg JNJ-38518168 or placebo once daily for 14 consecutive days (Period 2). At least a 20-day washout period will separate the dose administration in Period 1 and the first dose administration of Period 2. The duration of Part 1 will be approximately 78 days. Part 2 of this study will be a single-center, open-label (participants and study personnel will know the identity of the treatments), non-randomized, multiple dose, drug-drug interaction study. Eligible participants will receive a single oral dose of 2.5 mg of midazolam as oral solution on Day 1, three 10-mg tablets of JNJ-38518168 (30 mg) once daily for 14 consecutive days (Day 2 through Day 15); and another single oral dose of 2.5 mg midazolam on Day 15. The duration of Part 2 of the study will be approximately 42 days. Following an interim safety and PK data analysis, one additional treatment group may be studied to evaluate the effect of JNJ-38518168 at a dose lower than 30 mg once daily on the PK of midazolam. During Parts 1 or 2, participants may be admitted to the clinical unit for periods of up to 7 and 18 days, and follow-up return visits to the clinic will also be required.
- Conditions
- Healthy Male Volunteer
- Being tested
- JNJ-38518168 (30 mg), JNJ-38518168 (10 mg), JNJ-38518168 (3 mg), Placebo, Midazolam and JNJ-38518168
- Keywords
- Healthy male volunteer, JNJ-38518168, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-38518168 (30 mg)Drug
Type=range, unit=mg, number=30, form=tablet, route=oral use, in single and multiple doses for 14 days
JNJ-38518168 (10 mg)Drug
Type=range, unit=mg, number=10, form=tablet, route=oral use, in single and multiple doses for 14 days
JNJ-38518168 (3 mg)Drug
Type=range, unit=mg, number=3, form=tablet, route=oral use, in single and multiple doses for 14 days
PlaceboDrug
Form=tablet, route=oral use, for 14 days
Midazolam and JNJ-38518168Drug
Midazolam: Type=exact, unit=mg, number=2.5, form=oral solution; route=oral use, on Days 1 and 15; JNJ-38518168: Type=exact, unit=mg, number=30, form=tablet, route=oral use, once daily from Day 2 through Day 15
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: JNJ-38518168 (30 mg) |
| 2 | Experimental | Not described Receives: Drug: JNJ-38518168 (10 mg) |
| 3 | Experimental | Not described Receives: Drug: JNJ-38518168 (3 mg) |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
| 5 | Experimental | Not described Receives: Drug: Midazolam and JNJ-38518168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of Japanese participants with adverse events
Measured: Up to 10 weeks
Blood tests in Japanese participants
Measured: Up to 10 weeks
Clinical laboratory tests in Japanese participants
Measured: Up to 10 weeks
Electrocardiograms in Japanese participants
Measured: Up to 10 weeks
Blood levels of JNJ-38518168 in all participants
Measured: Up to 10 weeks
Secondary outcomes (4)
The number of Caucasian participants with adverse events
Measured: Up to 10 weeks
Blood tests in Caucasian participants
Measured: Up to 10 weeks
Clinical laboratory tests in Caucasian participants
Measured: Up to 10 weeks
Electrocardiograms in Caucasian participants
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteerStudies 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
- 94 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 & Development, L.L.C., Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442532
- Sponsor's protocol ID
- CR100669
- Other IDs
- 38518168ARA1002
- Status last verified
- Mar 2013
- First submitted
- 27 Sep 2011
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Single- and Multiple-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38518168 in Japanese and Caucasian Healthy Adult Male Subjects and an Open-Label Drug-Drug Interaction Study to Evaluate the Effect of JNJ-38518168 on the Pharmacokinetics of Midazolam, a CYP3A4 Substrate
- ClinicalTrials.gov ID
- NCT01442532
- Acronym / sponsor ID
- CR100669
- Conditions
- Healthy Male Volunteer
- Keywords
- Healthy male volunteer, JNJ-38518168, Midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Sep 2011 (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 Part 1 of this study is to evaluate the safety, tolerability, and pharmacokinetics ("PK", how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of JNJ-38518168 in comparison with placebo following single dose and 14 days of consecutive dosing in healthy Japanese and Caucasian adult male participants. Part 2 of this study will evaluate the effect of JNJ-38518168 on the pharmacokinetics of midazolam in healthy participants.
Detailed description
Participants will be assigned to either Part 1 or Part 2 of this study. Part 1 will be a single-center, double-blind (participants and study personnel will not know the identity of the treatments), randomized (treatment will be assigned by chance), single- and multiple-dose study. There will be 3 groups in Part 1, and the dosing will be as follows: Group A will receive a single oral dose of 30 mg JNJ-38518168 (given as three 10-mg tablets of JNJ-38518168) or placebo (a treatment identical in appearance to JNJ-38518168 but not containing active drug) (Period 1), and multiple oral doses of 30 mg JNJ 38518168 (given as three 10-mg tablets of JNJ-38518168) or matching placebo once daily for 14 consecutive days (Period 2); Group B will receive a single oral dose of 10 mg JNJ-38518168 or placebo (Period 1), and multiple oral doses of 10 mg JNJ-38518168 or placebo once daily for 14 consecutive days (Period 2); and Group C will receive a single oral dose of 3 mg JNJ-38518168 or placebo (Period 1), and multiple oral doses of 3 mg JNJ-38518168 or placebo once daily for 14 consecutive days (Period 2). At least a 20-day washout period will separate the dose administration in Period 1 and the first dose administration of Period 2. The duration of Part 1 will be approximately 78 days. Part 2 of this study will be a single-center, open-label (participants and study personnel will know the identity of the treatments), non-randomized, multiple dose, drug-drug interaction study. Eligible participants will receive a single oral dose of 2.5 mg of midazolam as oral solution on Day 1, three 10-mg tablets of JNJ-38518168 (30 mg) once daily for 14 consecutive days (Day 2 through Day 15); and another single oral dose of 2.5 mg midazolam on Day 15. The duration of Part 2 of the study will be approximately 42 days. Following an interim safety and PK data analysis, one additional treatment group may be studied to evaluate the effect of JNJ-38518168 at a dose lower than 30 mg once daily on the PK of midazolam. During Parts 1 or 2, participants may be admitted to the clinical unit for periods of up to 7 and 18 days, and follow-up return visits to the clinic will also be required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: JNJ-38518168 (30 mg) |
| 2 | Experimental | Drug: JNJ-38518168 (10 mg) |
| 3 | Experimental | Drug: JNJ-38518168 (3 mg) |
| 4 | Placebo comparator | Drug: Placebo |
| 5 | Experimental | Drug: Midazolam and JNJ-38518168 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Male, 20 to 55 years of age.
- Be either:
- Of Japanese descent who has resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report. Japanese participants must have a valid Japanese passport.
- or
- A non-Hispanic Caucasian participant who has Caucasian parents as determined by participant's verbal report.
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
- History of hypersensitivity to or intolerance of midazolam (Part 2 only)
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or admission to the study center in Period 1 as deemed appropriate by the investigator.
- Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or admission to the study center in Period 1 as deemed appropriate by the investigator.
- Has any known malignancy or a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study drug).
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-38518168 (30 mg)Type=range, unit=mg, number=30, form=tablet, route=oral use, in single and multiple doses for 14 days | Drug | 1 |
| JNJ-38518168 (10 mg)Type=range, unit=mg, number=10, form=tablet, route=oral use, in single and multiple doses for 14 days | Drug | 2 |
| JNJ-38518168 (3 mg)Type=range, unit=mg, number=3, form=tablet, route=oral use, in single and multiple doses for 14 days | Drug | 3 |
| PlaceboForm=tablet, route=oral use, for 14 days | Drug | 4 |
| Midazolam and JNJ-38518168Midazolam: Type=exact, unit=mg, number=2.5, form=oral solution; route=oral use, on Days 1 and 15; JNJ-38518168: Type=exact, unit=mg, number=30, form=tablet, route=oral use, once daily from Day 2 through Day 15 | Drug | 5 |
Primary outcome
The number of Japanese participants with adverse events
Time frame: Up to 10 weeks
Blood tests in Japanese participants
Time frame: Up to 10 weeks
Clinical laboratory tests in Japanese participants
Time frame: Up to 10 weeks
Electrocardiograms in Japanese participants
Time frame: Up to 10 weeks
Blood levels of JNJ-38518168 in all participants
Time frame: Up to 10 weeks
4 secondary outcomes
The number of Caucasian participants with adverse events
Time frame: Up to 10 weeks
Blood tests in Caucasian participants
Time frame: Up to 10 weeks
Clinical laboratory tests in Caucasian participants
Time frame: Up to 10 weeks
Electrocardiograms in Caucasian participants
Time frame: Up to 10 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 4 Mar 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 & Development, L.L.C., 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-38518168 (30 mg), JNJ-38518168 (10 mg) and JNJ-38518168 (3 mg) in people with Healthy Male Volunteer, 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 17 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 4 Mar 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. Some participants in this study may receive a placebo. 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 number of Japanese participants with adverse events (time frame: Up to 10 weeks). The study lists 5 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 4 Mar 2013.