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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics
following single oral doses of BMS-816336 in healthy male subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00979368
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00979368