Healthy VolunteersPhase 1NCT01964872
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Participants
A Phase 1 study testing JNJ-38877618: Part 1a, JNJ-38877618: Part 1b and JNJ-38877618: Part 1c (optional) in people with Healthy Volunteers, run by Janssen Cilag N.V./S.A. at 1 site in United Kingdom.
Trial summary
The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618 administered for 7 consecutive days in healthy adult male participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- JNJ-38877618: Part 1a, JNJ-38877618: Part 1b and JNJ-38877618: Part 1c (optional)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to May 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1
- Must have good exercise tolerance
- Agrees to protocol-defined use of effective contraception
- Body Mass Index between 20 and 30 kg/m2 and body weight not less than 65 kg
- Non-nicotine user for 6 months prior to screening
Who cannot join
- Current history of clinically significant medical illness
- History of drug or alcohol abuse within 5 years
- Routine consumption of >450 mg of caffeine per day
- Recent vaccination or acute illness
- Blood donation or major blood loss within 3 months prior to study drug administration
- Use of any prescription or over-the-counter medication (not including paracetamol), or herbal medication within 2 weeks of dosing of the study drug or a proton pump inhibitor within 6 weeks prior to dosing of study drug
Show all 10Show fewer
- Currently enrolled in an investigational study, or received an investigational drug or vaccine, or used an invasive investigational medical device within 3 months before the planned first dose of study drug
- Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
- Major surgery within 3 months before or after study participation or minor surgery within 6 weeks before screening, or 30 days after the last study drug administration
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Subjects
The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618 administered for 7 consecutive days in healthy adult male participants.
Read the detailed description
This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in healthy adult male participants aged 18 to 45 years (a single optional cohort in older healthy male participants aged 50 to 65 years may be included). If all optional cohorts are included, up to 144 participants may be enrolled. This study will consist of up to four parts. Part 1 contains up to 3 subparts: Part 1a is a double-blind, placebo-controlled, single ascending dose design (SAD) with a liquid formulation (Formulation A); Part 1b is an open-label (identity of assigned study drug will be known), single dose evaluation of a capsule formulation (Formulation B); and Part 1c is an optional open-label, single dose evaluation of a capsule formulation (Formulation C). Part 2 is the completion of the double-blind, placebo-controlled SAD after a formulation has been selected based on Parts 1a, 1b, and 1c (if applicable). Part 3 is a double-blind, placebo-controlled, multiple ascending dose design (MAD). Doses for Part 3 will be determined based on the safety, tolerability, and pharmacokinetics (study of what the body does to a drug) in Parts 1 and 2. Part 4 is an optional double-blind, placebo-controlled, single dose evaluation in older healthy male participants. Serial pharmacokinetic and pharmacodynamics (study of what a drug does to the body) samples will be collected and safety will be monitored throughout the study.
- Conditions
- Healthy Volunteers
- Being tested
- JNJ-38877618: Part 1a, JNJ-38877618: Part 1b, JNJ-38877618: Part 1c (optional), JNJ-38877618: Part 2, JNJ-38877618: Part 3
- Keywords
- Healthy volunteers, JNJ-38877618, Pharmacokinetic, Safety, Single-ascending dose, Multiple-ascending dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-38877618: Part 1aDrug
Single ascending dose administered orally in liquid formulation (Formulation A). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
JNJ-38877618: Part 1bDrug
Single dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
JNJ-38877618: Part 1c (optional)Drug
Single dose administered orally in an alternative capsule formulation (Formulation C). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
JNJ-38877618: Part 2Drug
Single ascending dose administered orally in the formulation selected based on Parts 1a, 1b, and 1c (if applicable). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
JNJ-38877618: Part 3Drug
Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally.
JNJ-38877618: Part 4 (optional)Drug
Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort.
Placebo: Parts 1a, 2, 3, and 4 (optional)Drug
Administered orally matched to study drug
| Study group | Role | What they receive |
|---|---|---|
| JNJ-38877618 | Experimental | Not described Receives: Drug: JNJ-38877618: Part 1a; Drug: JNJ-38877618: Part 1b; Drug: JNJ-38877618: Part 1c (optional); Drug: JNJ-38877618: Part 2; Drug: JNJ-38877618: Part 3; Drug: JNJ-38877618: Part 4 (optional) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo: Parts 1a, 2, 3, and 4 (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Measured: Up to 30 days after the last dose of study medication
Time to reach the maximum observed plasma concentration of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Area under the plasma concentration-time curve from time 0 to 24-hours post dose of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration
Measured: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Area under the plasma concentration-time curve from time 0 to infinite time of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Elimination half-life of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
First-order rate constant associated with the terminal portion of the curve of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Total clearance of drug after oral administration of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Apparent volume of distribution after oral administration of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Maximum observed plasma concentration during a dosing interval at steady state of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Minimum observed plasma concentration during a dosing interval at steady state of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Average plasma concentration over the dosing interval at steady state of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Trough observed plasma concentration at the end of dosing interval of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Time to reach the maximum observed plasma concentration of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Area under the plasma concentration-time curve during a dosing interval of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Area under the plasma concentration-time curve during a dosing interval at steady-state of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Total clearance of drug after oral administration of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Accumulation index of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Apparent volume of distribution at steady-state after oral administration of JNJ-38877618
Measured: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Secondary outcomes (1)
Maximum tolerated dose of JNJ-38877618
Measured: Up to 30 days after last dose of study medication (up to Part 2)
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 startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag N.V./S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Cilag N.V./S.A., Belgium Clinical Trial, Study director, Janssen Cilag N.V./S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964872
- Sponsor's protocol ID
- CR102784
- Other IDs
- 38877618EDI1001, 2013-002551-16
- Status last verified
- Sep 2014
- First submitted
- 15 Oct 2013
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01964872
- Acronym / sponsor ID
- CR102784
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, JNJ-38877618, Pharmacokinetic, Safety, Single-ascending dose, Multiple-ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Janssen Cilag N.V./S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 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 the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618 administered for 7 consecutive days in healthy adult male participants.
Detailed description
This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in healthy adult male participants aged 18 to 45 years (a single optional cohort in older healthy male participants aged 50 to 65 years may be included). If all optional cohorts are included, up to 144 participants may be enrolled. This study will consist of up to four parts. Part 1 contains up to 3 subparts: Part 1a is a double-blind, placebo-controlled, single ascending dose design (SAD) with a liquid formulation (Formulation A); Part 1b is an open-label (identity of assigned study drug will be known), single dose evaluation of a capsule formulation (Formulation B); and Part 1c is an optional open-label, single dose evaluation of a capsule formulation (Formulation C). Part 2 is the completion of the double-blind, placebo-controlled SAD after a formulation has been selected based on Parts 1a, 1b, and 1c (if applicable). Part 3 is a double-blind, placebo-controlled, multiple ascending dose design (MAD). Doses for Part 3 will be determined based on the safety, tolerability, and pharmacokinetics (study of what the body does to a drug) in Parts 1 and 2. Part 4 is an optional double-blind, placebo-controlled, single dose evaluation in older healthy male participants. Serial pharmacokinetic and pharmacodynamics (study of what a drug does to the body) samples will be collected and safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-38877618 | Experimental | Drug: JNJ-38877618: Part 1a, Drug: JNJ-38877618: Part 1b, Drug: JNJ-38877618: Part 1c (optional), Drug: JNJ-38877618: Part 2, Drug: JNJ-38877618: Part 3, Drug: JNJ-38877618: Part 4 (optional) |
| Placebo | Placebo comparator | Drug: Placebo: Parts 1a, 2, 3, and 4 (optional) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1
- Must have good exercise tolerance
- Agrees to protocol-defined use of effective contraception
- Body Mass Index between 20 and 30 kg/m2 and body weight not less than 65 kg
- Non-nicotine user for 6 months prior to screening
Key exclusion criteria (10 listed)
- Current history of clinically significant medical illness
- History of drug or alcohol abuse within 5 years
- Routine consumption of >450 mg of caffeine per day
- Recent vaccination or acute illness
- Blood donation or major blood loss within 3 months prior to study drug administration
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-38877618: Part 1aSingle ascending dose administered orally in liquid formulation (Formulation A). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg. | Drug | JNJ-38877618 |
| JNJ-38877618: Part 1bSingle dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg. | Drug | JNJ-38877618 |
| JNJ-38877618: Part 1c (optional)Single dose administered orally in an alternative capsule formulation (Formulation C). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg. | Drug | JNJ-38877618 |
| JNJ-38877618: Part 2Single ascending dose administered orally in the formulation selected based on Parts 1a, 1b, and 1c (if applicable). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg. | Drug | JNJ-38877618 |
| JNJ-38877618: Part 3Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally. | Drug | JNJ-38877618 |
| JNJ-38877618: Part 4 (optional)Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort. | Drug | JNJ-38877618 |
| Placebo: Parts 1a, 2, 3, and 4 (optional)Administered orally matched to study drug | Drug | Placebo |
Primary outcome
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Time frame: Up to 30 days after the last dose of study medication
Time to reach the maximum observed plasma concentration of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Area under the plasma concentration-time curve from time 0 to 24-hours post dose of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration
Time frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Area under the plasma concentration-time curve from time 0 to infinite time of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Elimination half-life of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
First-order rate constant associated with the terminal portion of the curve of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Total clearance of drug after oral administration of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Apparent volume of distribution after oral administration of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Maximum observed plasma concentration during a dosing interval at steady state of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Minimum observed plasma concentration during a dosing interval at steady state of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Average plasma concentration over the dosing interval at steady state of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Trough observed plasma concentration at the end of dosing interval of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Time to reach the maximum observed plasma concentration of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Area under the plasma concentration-time curve during a dosing interval of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Area under the plasma concentration-time curve during a dosing interval at steady-state of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Total clearance of drug after oral administration of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Accumulation index of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Apparent volume of distribution at steady-state after oral administration of JNJ-38877618
Time frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
1 secondary outcome
Maximum tolerated dose of JNJ-38877618
Time frame: Up to 30 days after last dose of study medication (up to Part 2)
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 12 Sep 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 Cilag N.V./S.A., Belgium Clinical Trial study director
Janssen Cilag N.V./S.A.
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-38877618: Part 1a, JNJ-38877618: Part 1b and JNJ-38877618: Part 1c (optional) in people with Healthy Volunteers, run by Janssen Cilag N.V./S.A. at 1 site in United Kingdom.
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 10 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 12 Sep 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 United Kingdom. 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?
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT) (time frame: Up to 30 days after the last dose of study medication). The study lists 19 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 12 Sep 2014.