HealthyPhase 1NCT01964651
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42165279 in Healthy Young and Elderly Participants
A Phase 1 study testing JNJ-42165279 50 mg, JNJ-42165279 100 mg and JNJ-42165279 30 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy, young and elderly, male and female participants after repeated oral dose administration. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-42165279 50 mg, JNJ-42165279 100 mg and JNJ-42165279 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2013to Oct 2014
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive
- Nonsmoker
- Healthy men between 18 and 55 years, inclusive (Cohorts A and B)
- Healthy women between 18 and 58 years, inclusive (Cohort C)
- Healthy men and women between 65 and 85 years of age, inclusive (Cohort D)
- Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an appropriate method of birth control for at least the same duration (Cohorts A, B, and D)
- Not be of childbearing potential due to either tubal ligation or hysterectomy, or who are postmenopausal (Cohorts C and D)
Who cannot join
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission
- Clinically significant abnormal physical examination, vital signs or electrocardiogram at screening or admission
- History of, or current, significant medical illness including (but not limited to) cardiac disease, hematological disease, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
- History of epilepsy or fits or unexplained black-outs
- Cohorts A and B only: a contraindication for spinal puncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42165279 in Healthy Young and Elderly Subjects
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy, young and elderly, male and female participants after repeated oral dose administration.
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 (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study) trial that will be conducted in two parts. Thirty two (32) healthy participants are planned to be included in total, in four cohorts (groups). Participants in each cohort will receive JNJ-42165279 (n=6) or placebo (n=2) once-daily for 10 consecutive days. In Part 1, two cohorts of healthy male participants, 18 to 55 years of age, will be enrolled. Cohort A will receive 50 mg JNJ-42165279 or placebo for 10 days, and Cohort B will receive 30 mg JNJ-42165279 or placebo for 10 days. In Part 2, Cohort C will consist of 8 healthy female participants of non-childbearing potential (surgically sterile or postmenopausal), 18 to 58 years of age, who will receive 100 mg JNJ-42165279 or placebo for 10 days. Cohort D will consist of 8 healthy elderly male or female participants, from 65 to 85 years of age, who will receive 100 mg JNJ-42165279 or placebo for 10 days. The dose may be adapted before each cohort starts based on available data. The maximum dose will not exceed 100 mg once-daily. For all participants, this study will consist of an eligibility screening examination (between 28 and 3 days prior to the first dose administration), a double-blind treatment phase consisting of 2 days before dosing, 10 dosing days (Day 1 to 10), 4 days after dosing (Day 11 to 14), and a follow-up examination (within 7 to 14 days after last dose administration). The total study duration for each participant will not exceed 8 weeks.
- Conditions
- Healthy
- Being tested
- JNJ-42165279 50 mg, JNJ-42165279 100 mg, JNJ-42165279 30 mg, Placebo
- Keywords
- Healthy, JNJ-42165279, Pharmacokinetics, Elderly, Young
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42165279 50 mgDrug
JNJ-42165279 50 mg orally administered once daily for 10 days.
JNJ-42165279 100 mgDrug
JNJ-42165279 100 mg orally administered once daily for 10 days.
JNJ-42165279 30 mgDrug
JNJ-42165279 30 mg orally administered once daily for 10 days.
PlaceboDrug
Matching placebo orally administered once daily for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Part 1) | Experimental | Healthy male participants, 18 to 55 years of age. Receives: Drug: JNJ-42165279 50 mg; Drug: Placebo |
| Cohort B (Part 1) | Experimental | Healthy male participants, 18 to 55 years of age. Receives: Drug: JNJ-42165279 30 mg; Drug: Placebo |
| Cohort C (Part 2) | Experimental | Healthy female participants of nonchildbearing potential (surgically sterile or postmenopausal), 18 to 58 years of age. Receives: Drug: JNJ-42165279 100 mg; Drug: Placebo |
| Cohort D (Part 2) | Experimental | Healthy elderly male or female participants, from 65 to 85 years of age. Receives: Drug: JNJ-42165279 100 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of JNJ-42165279
Measured: 2 weeks
Urine concentrations of JNJ-42165279
Measured: 2 weeks
Concentrations in cerebrospinal fluid of JNJ-42165279
Measured: 2 weeks
The number of participants with adserve events as a measure of safety and tolerability
Measured: Approximately 8 weeks
Secondary outcomes (9)
Enzyme fatty acid amide hydrolase inhibition, as measured in white blood cells (WBCs)
Measured: Approximately 4 weeks
Plasma concentrations of N-arachidonoylethanolamine (anandamide)
Measured: 2 weeks
Plasma concentrations of palmitoylethanolamide
Measured: 2 weeks
Plasma concentrations of oleoylethanolamide
Measured: 2 weeks
Serum concentrations of prolactin
Measured: 10 days
Saliva concentrations of cortisol
Measured: 10 days
Concentrations in cerebrospinal fluid of N-arachidonoylethanolamine (anandamide) or its metabolites
Measured: 9 days
Concentrations in cerebrospinal fluid of palmitoylethanolamide or its metabolites
Measured: 9 days
Concentrations in cerebrospinal fluid of oleoylethanolamide or its metabolites
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
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
- 40 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
- NCT01964651
- Sponsor's protocol ID
- CR102575
- Other IDs
- 42165279EDI1002, 2013-002309-67
- Status last verified
- Dec 2014
- First submitted
- 14 Oct 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42165279 in Healthy Young and Elderly Subjects
- ClinicalTrials.gov ID
- NCT01964651
- Acronym / sponsor ID
- CR102575
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-42165279, Pharmacokinetics, Elderly, Young
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Oct 2013 (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 safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy, young and elderly, male and female participants after repeated oral dose administration.
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 (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study) trial that will be conducted in two parts. Thirty two (32) healthy participants are planned to be included in total, in four cohorts (groups). Participants in each cohort will receive JNJ-42165279 (n=6) or placebo (n=2) once-daily for 10 consecutive days. In Part 1, two cohorts of healthy male participants, 18 to 55 years of age, will be enrolled. Cohort A will receive 50 mg JNJ-42165279 or placebo for 10 days, and Cohort B will receive 30 mg JNJ-42165279 or placebo for 10 days. In Part 2, Cohort C will consist of 8 healthy female participants of non-childbearing potential (surgically sterile or postmenopausal), 18 to 58 years of age, who will receive 100 mg JNJ-42165279 or placebo for 10 days. Cohort D will consist of 8 healthy elderly male or female participants, from 65 to 85 years of age, who will receive 100 mg JNJ-42165279 or placebo for 10 days. The dose may be adapted before each cohort starts based on available data. The maximum dose will not exceed 100 mg once-daily. For all participants, this study will consist of an eligibility screening examination (between 28 and 3 days prior to the first dose administration), a double-blind treatment phase consisting of 2 days before dosing, 10 dosing days (Day 1 to 10), 4 days after dosing (Day 11 to 14), and a follow-up examination (within 7 to 14 days after last dose administration). The total study duration for each participant will not exceed 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Part 1) | Experimental | Drug: JNJ-42165279 50 mg, Drug: PlaceboHealthy male participants, 18 to 55 years of age. |
| Cohort B (Part 1) | Experimental | Drug: JNJ-42165279 30 mg, Drug: PlaceboHealthy male participants, 18 to 55 years of age. |
| Cohort C (Part 2) | Experimental | Drug: JNJ-42165279 100 mg, Drug: PlaceboHealthy female participants of nonchildbearing potential (surgically sterile or postmenopausal), 18 to 58 years of age. |
| Cohort D (Part 2) | Experimental | Drug: JNJ-42165279 100 mg, Drug: PlaceboHealthy elderly male or female participants, from 65 to 85 years of age. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive
- Nonsmoker
- Healthy men between 18 and 55 years, inclusive (Cohorts A and B)
- Healthy women between 18 and 58 years, inclusive (Cohort C)
- Healthy men and women between 65 and 85 years of age, inclusive (Cohort D)
Key exclusion criteria (5 listed)
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission
- Clinically significant abnormal physical examination, vital signs or electrocardiogram at screening or admission
- History of, or current, significant medical illness including (but not limited to) cardiac disease, hematological disease, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
- History of epilepsy or fits or unexplained black-outs
- Cohorts A and B only: a contraindication for spinal puncture
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-42165279 50 mgJNJ-42165279 50 mg orally administered once daily for 10 days. | Drug | Cohort A (Part 1) |
| JNJ-42165279 100 mgJNJ-42165279 100 mg orally administered once daily for 10 days. | Drug | Cohort C (Part 2), Cohort D (Part 2) |
| JNJ-42165279 30 mgJNJ-42165279 30 mg orally administered once daily for 10 days. | Drug | Cohort B (Part 1) |
| PlaceboMatching placebo orally administered once daily for 10 days. | Drug | Cohort A (Part 1), Cohort B (Part 1), Cohort C (Part 2), Cohort D (Part 2) |
Primary outcome
Plasma concentrations of JNJ-42165279
Time frame: 2 weeks
Urine concentrations of JNJ-42165279
Time frame: 2 weeks
Concentrations in cerebrospinal fluid of JNJ-42165279
Time frame: 2 weeks
The number of participants with adserve events as a measure of safety and tolerability
Time frame: Approximately 8 weeks
9 secondary outcomes
Enzyme fatty acid amide hydrolase inhibition, as measured in white blood cells (WBCs)
Time frame: Approximately 4 weeks
Plasma concentrations of N-arachidonoylethanolamine (anandamide)
Time frame: 2 weeks
Plasma concentrations of palmitoylethanolamide
Time frame: 2 weeks
Plasma concentrations of oleoylethanolamide
Time frame: 2 weeks
Serum concentrations of prolactin
Time frame: 10 days
Saliva concentrations of cortisol
Time frame: 10 days
Concentrations in cerebrospinal fluid of N-arachidonoylethanolamine (anandamide) or its metabolites
Time frame: 9 days
Concentrations in cerebrospinal fluid of palmitoylethanolamide or its metabolites
Time frame: 9 days
Concentrations in cerebrospinal fluid of oleoylethanolamide or its metabolites
Time frame: 9 days
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 Dec 2014.
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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-42165279 50 mg, JNJ-42165279 100 mg and JNJ-42165279 30 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 7 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 Dec 2014. 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 Belgium. 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-42165279 (time frame: 2 weeks). 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 3 Dec 2014.