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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00979368




Registration number
NCT00979368
Ethics application status
Date submitted
17/09/2009
Date registered
18/09/2009
Date last updated
23/02/2011

Titles & IDs
Public title
Safety Study of BMS-816336 in Healthy Male Subjects
Scientific title
Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-816336 in Healthy Male Subjects
Secondary ID [1] 0 0
MB124-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Non-Insulin-Dependent 0 0
Dyslipidemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-816336
Treatment: Drugs - BMS-816336
Treatment: Drugs - BMS-816336
Treatment: Drugs - BMS-816336
Treatment: Drugs - BMS-816336
Treatment: Drugs - Placebo

Active comparator: BMS-816336 or placebo (Panel 1) -

Active comparator: BMS-816336 or placebo (Panel 2) -

Active comparator: BMS-816336 or placebo (Panel 3) -

Active comparator: BMS-816336 or placebo (Panel 4) -

Active comparator: BMS-816336 or placebo (Panel 5) -


Treatment: Drugs: BMS-816336
Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days

Treatment: Drugs: BMS-816336
Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days

Treatment: Drugs: BMS-816336
Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days

Treatment: Drugs: BMS-816336
Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days

Treatment: Drugs: BMS-816336
Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days

Treatment: Drugs: Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Exposure to the investigational drug will be measured to assess safety and tolerability
Timepoint [1] 0 0
Within 72 hours following dosing
Secondary outcome [1] 0 0
To assess the single dose Pharmacokinetics of BMS-816336
Timepoint [1] 0 0
During 72 hours following dosing

Eligibility
Key inclusion criteria
* Healthy male subjects
* BMI of 18 to 32 kg/m²
* Men only, ages 18-55 years
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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)
* Second- or third-degree A-V block or clinically relevant ECG abnormalities
* History of allergy to 11-ß-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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00979368