Diabetes Mellitus, Non-Insulin-DependentPhase 1NCT00979368
Safety Study of BMS-816336 in Healthy Male Subjects
A Phase 1 study testing BMS-816336 in people with Diabetes Mellitus, Non-Insulin-Dependent and Dyslipidemia, run by Bristol-Myers Squibb at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects. 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
- Diabetes Mellitus, Non-Insulin-Dependent, Dyslipidemia
- What is being tested?
- BMS-816336
- 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 siteAustralia
- Study dates
- Nov 2009to Feb 2010
- 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
- Healthy male subjects
- BMI of 18 to 32 kg/m²
- Men only, ages 18-55 years
Who cannot join
- Sexually active men not using effective birth control if their partners are WOCBP
- Any significant acute or chronic medical illness
- Family history of Gilbert's disease
- History of Pancreatitis
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EGG or clinical laboratory determinations
- QTc interval > 450 msec (corrected for heart rate using Fridericia's correction method, QTcF)
Show all 13Show fewer
- Second- or third-degree A-V block or clinically relevant ECG abnormalities
- History of allergy to 11-β-HSD-1 inhibitors or related compounds
- Prior exposure to BMS-816336
- Use of St. John's Wort (Hypericum) within 4 weeks prior to the first dose of study drug and throughout the study
- Use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration
- Use of any glucocorticoid topical creams within 4 weeks of study drug administration
- Use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-816336 in Healthy Male Subjects
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.
- Being tested
- BMS-816336, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-816336Drug
Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days
BMS-816336Drug
Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days
BMS-816336Drug
Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days
BMS-816336Drug
Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days
BMS-816336Drug
Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days
PlaceboDrug
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-816336 or placebo (Panel 1) | Active comparator | Not described Receives: Drug: BMS-816336; Drug: Placebo |
| BMS-816336 or placebo (Panel 2) | Active comparator | Not described Receives: Drug: BMS-816336; Drug: Placebo |
| BMS-816336 or placebo (Panel 3) | Active comparator | Not described Receives: Drug: BMS-816336; Drug: Placebo |
| BMS-816336 or placebo (Panel 4) | Active comparator | Not described Receives: Drug: BMS-816336; Drug: Placebo |
| BMS-816336 or placebo (Panel 5) | Active comparator | Not described Receives: Drug: BMS-816336; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to the investigational drug will be measured to assess safety and tolerability
Measured: Within 72 hours following dosing
Secondary outcomes (1)
To assess the single dose Pharmacokinetics of BMS-816336
Measured: During 72 hours following dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979368
- Sponsor's protocol ID
- MB124-001
- Status last verified
- Oct 2009
- First submitted
- 17 Sep 2009
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-816336 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00979368
- Acronym / sponsor ID
- MB124-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 Sep 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.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BMS-816336 or placebo (Panel 1) | Active comparator | Drug: BMS-816336, Drug: Placebo |
| BMS-816336 or placebo (Panel 2) | Active comparator | Drug: BMS-816336, Drug: Placebo |
| BMS-816336 or placebo (Panel 3) | Active comparator | Drug: BMS-816336, Drug: Placebo |
| BMS-816336 or placebo (Panel 4) | Active comparator | Drug: BMS-816336, Drug: Placebo |
| BMS-816336 or placebo (Panel 5) | Active comparator | Drug: BMS-816336, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects
- BMI of 18 to 32 kg/m²
- Men only, ages 18-55 years
Key exclusion criteria (13 listed)
- Sexually active men not using effective birth control if their partners are WOCBP
- Any significant acute or chronic medical illness
- Family history of Gilbert's disease
- History of Pancreatitis
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EGG or clinical laboratory determinations
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 |
|---|---|---|
| BMS-816336Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days | Drug | BMS-816336 or placebo (Panel 1) |
| BMS-816336Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days | Drug | BMS-816336 or placebo (Panel 2) |
| BMS-816336Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days | Drug | BMS-816336 or placebo (Panel 3) |
| BMS-816336Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days | Drug | BMS-816336 or placebo (Panel 4) |
| BMS-816336Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days | Drug | BMS-816336 or placebo (Panel 5) |
| PlaceboSuspension, Oral, 0 mg, Once on Day 1 only, 4 days | Drug | BMS-816336 or placebo (Panel 1), BMS-816336 or placebo (Panel 2), BMS-816336 or placebo (Panel 3), BMS-816336 or placebo (Panel 4), BMS-816336 or placebo (Panel 5) |
Primary outcome
Exposure to the investigational drug will be measured to assess safety and tolerability
Time frame: Within 72 hours following dosing
1 secondary outcome
To assess the single dose Pharmacokinetics of BMS-816336
Time frame: During 72 hours following dosing
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 23 Feb 2011.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 BMS-816336 in people with Diabetes Mellitus, Non-Insulin-Dependent and Dyslipidemia, run by Bristol-Myers Squibb at 1 site in Australia.
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 13 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 23 Feb 2011. 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 Australia. 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?
Exposure to the investigational drug will be measured to assess safety and tolerability (time frame: Within 72 hours following dosing). 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 23 Feb 2011.