Diabetes Mellitus, Type 2Phase 1NCT00910923
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-38431055 in Healthy Male Volunteers
A Phase 1 study testing JNJ-38431055 in people with Diabetes Mellitus, Type 2, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
This will be a single center study conducted in two parts. Part 1 will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of JNJ-38431055 in healthy male volunteers. Part 2 will assess the effect of food on the pharmacokinetics of JNJ-38431055. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- JNJ-38431055
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Apr 2009
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
- Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests performed
- Volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Who cannot join
- History of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
- Smoker or tobacco user within the past 6 months
- History of recent major surgery (within 6 months of study start)
- Positive test for alcohol and/or drugs of abuse
- Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
- Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.
About this study
Official title: Single Ascending Dose
This will be a single center study conducted in two parts. Part 1 will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of JNJ-38431055 in healthy male volunteers. Part 2 will assess the effect of food on the pharmacokinetics of JNJ-38431055.
Read the detailed description
The study includes 2 Parts and will be conducted at a single center. Part 1 is a randomized (study drug assigned by chance), double-blind (neither the volunteer or investigator knows the name of the assigned study drug), placebo-controlled (placebo is a substance that looks the same as JNJ-38431055 but contains no JNJ-38431055), single ascending dose study. In Part 1, study drug (i.e., JNJ-38431055 or placebo) will be administered orally as single doses on Day 1 or three treatment periods. In Part 1, for each volunteer, the study will consist of a screening evaluation visit, 3 periods of double-blind treatment, and a final, follow-up examination. The total study duration for each volunteer will be approximately 9 weeks. Part 2 is a randomized, open-label, 2-period crossover study to evaluate the effect of administering JNJ-38431055 together with food on the pharmacokinetics of JNJ-38431055, as compared to administration in the fasting condition. In Part 2, study drug (JNJ-38431055 will be administered orally as single doses on Day 1 or two treatment periods. There will be at least 7 days between doses. In Part 1, study drug (i.e., JNJ-38431055 or placebo) will be administered orally as single doses on Day 1 of three treatment periods. In Part 2, study drug (JNJ-38431055) will be administered orally as single doses on Day 1 of two treatment periods.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- JNJ-38431055
- Keywords
- Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-38431055Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of JNJ-38431055
Secondary outcomes (1)
To assess the pharmacodynamic effects of JNJ-38431055 on plasma glucose and insulin, during a Meal Tolerance Test (MTT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910923
- Sponsor's protocol ID
- CR015703
- Status last verified
- Oct 2009
- First submitted
- 19 Mar 2009
- Last updated
- 6 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Ascending Dose
- ClinicalTrials.gov ID
- NCT00910923
- Acronym / sponsor ID
- CR015703
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 1 Jun 2009 (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.
This will be a single center study conducted in two parts. Part 1 will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of JNJ-38431055 in healthy male volunteers. Part 2 will assess the effect of food on the pharmacokinetics of JNJ-38431055.
Detailed description
The study includes 2 Parts and will be conducted at a single center. Part 1 is a randomized (study drug assigned by chance), double-blind (neither the volunteer or investigator knows the name of the assigned study drug), placebo-controlled (placebo is a substance that looks the same as JNJ-38431055 but contains no JNJ-38431055), single ascending dose study. In Part 1, study drug (i.e., JNJ-38431055 or placebo) will be administered orally as single doses on Day 1 or three treatment periods. In Part 1, for each volunteer, the study will consist of a screening evaluation visit, 3 periods of double-blind treatment, and a final, follow-up examination. The total study duration for each volunteer will be approximately 9 weeks. Part 2 is a randomized, open-label, 2-period crossover study to evaluate the effect of administering JNJ-38431055 together with food on the pharmacokinetics of JNJ-38431055, as compared to administration in the fasting condition. In Part 2, study drug (JNJ-38431055 will be administered orally as single doses on Day 1 or two treatment periods. There will be at least 7 days between doses. In Part 1, study drug (i.e., JNJ-38431055 or placebo) will be administered orally as single doses on Day 1 of three treatment periods. In Part 2, study drug (JNJ-38431055) will be administered orally as single doses on Day 1 of two treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
- Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests performed
- Volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Key exclusion criteria (6 listed)
- History of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
- Smoker or tobacco user within the past 6 months
- History of recent major surgery (within 6 months of study start)
- Positive test for alcohol and/or drugs of abuse
- Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
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-38431055 | Drug | – |
Primary outcome
To assess the safety and tolerability of JNJ-38431055
1 secondary outcome
To assess the pharmacodynamic effects of JNJ-38431055 on plasma glucose and insulin, during a Meal Tolerance Test (MTT)
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 Oct 2009.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-38431055 in people with Diabetes Mellitus, Type 2, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 6 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 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
To assess the safety and tolerability of JNJ-38431055. 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 Oct 2009.