Healthy VolunteersPhase 1NCT01650597
A Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Participants
A Phase 1 study testing JNJ-42165279 2.5 - 500 mg oral and JNJ-42165279 100 mg oral in people with Healthy Volunteers and Pharmacokinetics, run by Janssen-Cilag International NV at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single ascending doses as well as repeated doses of JNJ-42165279 in healthy male participants. 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 Volunteers, Pharmacokinetics
- What is being tested?
- JNJ-42165279 2.5 - 500 mg oral and JNJ-42165279 100 mg oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2011to May 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
- Has a body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg.
- Must adhere to required contraception (subject and partner, if applicable) during the study and for 3 months after study
- Must agree to not donate sperm during the study and for 3 months after receiving the last dose of study drug
Who cannot join
- Has history of or current clinically significant medical illness including 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, recent surgery or trauma.
- Has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
- Has clinically significant abnormal values for hematology, clinical chemistry, coagulation, or urinalysis at screening or at first admission to the study center.
- Has clinically significant abnormal physical examination, neurological examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at first admission to the study center. Subjects with a QTcF interval >450 msec or QRS interval ≥110 msec will be excluded.
- Has use of any prescription or nonprescription medications or herbal supplements, except for paracetamol, within 14 days before the first dose of study drug. Paracetamol is not allowed within 1 day (Day -1) before the first dose of study drug.
- Has known allergy, hypersensitivity, or intolerance to hypromellose (the excipient of JNJ-42165279)
Show all 12Show fewer
- Has Known allergy to heparin or history of heparin induced thrombocytopenia
- Has positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B core antibody (HBcAB), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV)
- Has history of significant drug or alcohol abuse within past 5 years, or has a positive drug screen
- Smoking or use of nicotine-containing substances within past 2 months
- Blood donation or blood loss within past 3 months
- Recent use of an investigational drug or device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Subjects
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single ascending doses as well as repeated doses of JNJ-42165279 in healthy male participants.
Read the detailed description
This is a single-site, randomized (participants are assigned to treatment by chance), double-blind study (neither physician nor participant knows whether the participant is receiving active treatment or placebo). Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. This study consists of two parts (part 1, single dosing and part 2, multiple dosing). Part 1: An alternating panel design will be used, whereby the first panel of 9 participants will receive the first, third, and fifth administered doses, while the second panel of 9 participants will receive the second, fourth, and sixth administered doses.Up to 2 additional dosings (1 per panel) may be evaluated to further understand the study drug. For each dose administration, 6 participants will be assigned to active treatment and 3 to placebo. Each participant will receive JNJ-42165279 on 2 occasions and placebo once during the first 3 dosings. The planned doses of JNJ-42165279 range from 2.5 to 500 mg. The sponsor and investigator will review blinded data associated with each dose prior to administration of the next dose. Participants will check into the study center the morning prior to each dosing (Day -1) and will remain at the center until discharge 72 hours after dosing (Day 4). Participants will be dosed approximately every 4 weeks. Part 2: A separate cohort of 9 healthy male volunteers will receive repeated daily dosing of 100 mg JNJ-42165279 or placebo (6 participants will receive JNJ-42165279 and 3 participants will receive placebo) for 6 consecutive days. Participants will check into the study center the morning prior to their first dosing (Day -1) and will remain at the center until discharge 72 hours after receiving their last dose on Day 6. Participants in Part 1 and 2 will return for a follow-up visit 7 to 14 days after their final discharge from the study center.
- Conditions
- Healthy Volunteers, Pharmacokinetics
- Being tested
- JNJ-42165279 2.5 - 500 mg oral, Placebo, JNJ-42165279 100 mg oral
- Keywords
- Healthy volunteers, Pharmacokinetics, Free fatty amides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42165279 2.5 - 500 mg oralDrug
Type=exact number, unit=mg, numbers=2.5, 10, 30, 100, 250 and 500, form=suspension, route=oral use. One single dose administered orally.
PlaceboDrug
Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally.
JNJ-42165279 100 mg oralDrug
Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Panel 1 | Experimental | The participants will receive 3 or 4 ascending doses (2.5, 10, 30, 100, 250, 500 mg) of JNJ-42165279 and placebo during the study. Receives: Drug: JNJ-42165279 2.5 - 500 mg oral; Drug: Placebo |
| Part 1 - Panel 2 | Experimental | The participants will receive 3 or 4 ascending doses (2.5, 10, 30, 100, 250, 500 mg) of JNJ-42165279 and placebo during the study. Receives: Drug: JNJ-42165279 2.5 - 500 mg oral; Drug: Placebo |
| Part 2 (parallel)- additional cohort | Experimental | The participants will receive repeated daily dosing of 100 mg JNJ-42165279 or placebo for 6 consecutive days. Receives: Drug: Placebo; Drug: JNJ-42165279 100 mg oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidents of adverse events amongst participants (Part 1)
As a measure of safety.
Measured: Day -21 to Day 114 (~19 wks)
Incidents of adverse events amongst participants (Part 2)
Measured: Day -21 to Day 23 (~6 wks)
Pharmacokinetics of JNJ-42165279 as measured by Cmax (Part 1)
Cmax is defined as maximum plasma concentration of JNJ-42165279.
Measured: Day 1 to Day 4
Pharmacokinetics of JNJ-42165279 as measured by Cmax (Part 2)
Measured: Day 1 to Day 7
Pharmacokinetics of JNJ-42165279 as measured by AUC (Part 1)
AUC is defined area under the plasma concentration time curve from 0 to t hours post dosing of JNJ-42165279.
Measured: Day 1 to Day 4
Pharmacokinetics of JNJ-42165279 as measured by AUC (Part 2)
Measured: Day 1 to Day 7
Secondary outcomes (8)
Fatty acid amide hydrolase (FAAH) inhibition in white blood cells (WBCs) (Part 1)
Measured: Day 1 to Day 4
FAAH inhibition in WBC (Part 2)
Measured: Day 1 to Day 7 and Day 9
Effects on mood (Part 1)
This is measured by scores on Patient Reported Outcome (PRO) questionnaires (Profile of Mood States [POMS], State version of the State-Trait Anxiety Inventory [STAIS], and the Exercise-Induced Feeling Inventory [EFI]). The POMS is a valid and reliable self-report scale that can be utilized to assess both positive and negative, transient, fluctuating mood states. The STAIS is a commonly-used, validated instrument to assess anxiety. The EFI assesses emotions commonly associated with exercise.
Measured: Day 1 and Day 2
Effects on mood (Part 2)
Measured: Day 1 to Day 9
Effects on cognition (Part 1)
This is assessed by the time to complete Trail Making Test (TMT).
Measured: Day -1 and Day 1
Effects on cognition (Part 2)
Measured: Day -1, Day 1 and Day 6
Effects on pain tolerance (Part 1)
This is measured by pressure pain tolerance threshold using an electronic pressure algometer.
Measured: Day -1 to Day 2
Effects on drowsiness (Part 2)
This is measured by Stanford Sleepiness Scale (SSS). This 7 point Likerttype scale is used to rate the drowsiness with the descriptors ranging from "feeling active, vital, alert, and wide awake" (score= 1) to "no longer fighting sleep, sleep onset soon, and having dream like thoughts" (score=7).
Measured: Day 1 to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startAug 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Principal investigator, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650597
- Sponsor's protocol ID
- CR100707
- Other IDs
- 42165279EDI1001, 2011-002861-39
- Status last verified
- May 2014
- First submitted
- 24 Jul 2012
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01650597
- Acronym / sponsor ID
- CR100707
- Conditions
- Healthy Volunteers, Pharmacokinetics
- Keywords
- Healthy volunteers, Pharmacokinetics, Free fatty amides
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Jul 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 single ascending doses as well as repeated doses of JNJ-42165279 in healthy male participants.
Detailed description
This is a single-site, randomized (participants are assigned to treatment by chance), double-blind study (neither physician nor participant knows whether the participant is receiving active treatment or placebo). Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. This study consists of two parts (part 1, single dosing and part 2, multiple dosing). Part 1: An alternating panel design will be used, whereby the first panel of 9 participants will receive the first, third, and fifth administered doses, while the second panel of 9 participants will receive the second, fourth, and sixth administered doses.Up to 2 additional dosings (1 per panel) may be evaluated to further understand the study drug. For each dose administration, 6 participants will be assigned to active treatment and 3 to placebo. Each participant will receive JNJ-42165279 on 2 occasions and placebo once during the first 3 dosings. The planned doses of JNJ-42165279 range from 2.5 to 500 mg. The sponsor and investigator will review blinded data associated with each dose prior to administration of the next dose. Participants will check into the study center the morning prior to each dosing (Day -1) and will remain at the center until discharge 72 hours after dosing (Day 4). Participants will be dosed approximately every 4 weeks. Part 2: A separate cohort of 9 healthy male volunteers will receive repeated daily dosing of 100 mg JNJ-42165279 or placebo (6 participants will receive JNJ-42165279 and 3 participants will receive placebo) for 6 consecutive days. Participants will check into the study center the morning prior to their first dosing (Day -1) and will remain at the center until discharge 72 hours after receiving their last dose on Day 6. Participants in Part 1 and 2 will return for a follow-up visit 7 to 14 days after their final discharge from the study center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Panel 1 | Experimental | Drug: JNJ-42165279 2.5 - 500 mg oral, Drug: PlaceboThe participants will receive 3 or 4 ascending doses (2.5, 10, 30, 100, 250, 500 mg) of JNJ-42165279 and placebo during the study. |
| Part 1 - Panel 2 | Experimental | Drug: JNJ-42165279 2.5 - 500 mg oral, Drug: PlaceboThe participants will receive 3 or 4 ascending doses (2.5, 10, 30, 100, 250, 500 mg) of JNJ-42165279 and placebo during the study. |
| Part 2 (parallel)- additional cohort | Experimental | Drug: Placebo, Drug: JNJ-42165279 100 mg oralThe participants will receive repeated daily dosing of 100 mg JNJ-42165279 or placebo for 6 consecutive days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Has a body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg.
- Must adhere to required contraception (subject and partner, if applicable) during the study and for 3 months after study
- Must agree to not donate sperm during the study and for 3 months after receiving the last dose of study drug
Key exclusion criteria (12 listed)
- Has history of or current clinically significant medical illness including 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, recent surgery or trauma.
- Has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
- Has clinically significant abnormal values for hematology, clinical chemistry, coagulation, or urinalysis at screening or at first admission to the study center.
- Has clinically significant abnormal physical examination, neurological examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at first admission to the study center. Subjects with a QTcF interval >450 msec or QRS interval ≥110 msec will be excluded.
- Has use of any prescription or nonprescription medications or herbal supplements, except for paracetamol, within 14 days before the first dose of study drug. Paracetamol is not allowed within 1 day (Day -1) before the first dose 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-42165279 2.5 - 500 mg oralType=exact number, unit=mg, numbers=2.5, 10, 30, 100, 250 and 500, form=suspension, route=oral use. One single dose administered orally. | Drug | Part 1 - Panel 1, Part 1 - Panel 2 |
| PlaceboType=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally. | Drug | Part 1 - Panel 1, Part 1 - Panel 2, Part 2 (parallel)- additional cohort |
| JNJ-42165279 100 mg oralType=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally. | Drug | Part 2 (parallel)- additional cohort |
Primary outcome
Incidents of adverse events amongst participants (Part 1)
Time frame: Day -21 to Day 114 (~19 wks)
As a measure of safety.
Incidents of adverse events amongst participants (Part 2)
Time frame: Day -21 to Day 23 (~6 wks)
Pharmacokinetics of JNJ-42165279 as measured by Cmax (Part 1)
Time frame: Day 1 to Day 4
Cmax is defined as maximum plasma concentration of JNJ-42165279.
Pharmacokinetics of JNJ-42165279 as measured by Cmax (Part 2)
Time frame: Day 1 to Day 7
Pharmacokinetics of JNJ-42165279 as measured by AUC (Part 1)
Time frame: Day 1 to Day 4
AUC is defined area under the plasma concentration time curve from 0 to t hours post dosing of JNJ-42165279.
Pharmacokinetics of JNJ-42165279 as measured by AUC (Part 2)
Time frame: Day 1 to Day 7
8 secondary outcomes
Fatty acid amide hydrolase (FAAH) inhibition in white blood cells (WBCs) (Part 1)
Time frame: Day 1 to Day 4
FAAH inhibition in WBC (Part 2)
Time frame: Day 1 to Day 7 and Day 9
Effects on mood (Part 1)
Time frame: Day 1 and Day 2
Effects on mood (Part 2)
Time frame: Day 1 to Day 9
Effects on cognition (Part 1)
Time frame: Day -1 and Day 1
Effects on cognition (Part 2)
Time frame: Day -1, Day 1 and Day 6
Effects on pain tolerance (Part 1)
Time frame: Day -1 to Day 2
Effects on drowsiness (Part 2)
Time frame: Day 1 to Day 6
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 6 Jul 2017.
Related trials for Healthy Volunteers
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Imaging Techniques in MRI
Cardiac Risk Factors, Healthy
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-Cilag International NV Clinical Trial principal investigator
Janssen-Cilag International NV
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 2.5 - 500 mg oral and JNJ-42165279 100 mg oral in people with Healthy Volunteers and Pharmacokinetics, run by Janssen-Cilag International NV 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 3 inclusion and 12 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 6 Jul 2017. 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?
Incidents of adverse events amongst participants (Part 1) (time frame: Day -21 to Day 114 (~19 wks)). 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 6 Jul 2017.