Safety Study of BMS-816336 in Healthy Male Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Non-Insulin-Dependent; Dyslipidemia

Treatments: Drug: Placebo; Drug: BMS-816336

Study type: Interventional

Funder types: Industry

Identifiers

NCT00979368

MB124-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects
• BMI of 18 to 32 kg/m²
• Men only, ages 18-55 years

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-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 design

40 participants in 5 patient groups

BMS-816336 or placebo (Panel 1)

Active Comparator group

Treatment:

Drug: BMS-816336

Drug: BMS-816336

Drug: BMS-816336

Drug: BMS-816336

Drug: Placebo

Drug: BMS-816336

BMS-816336 or placebo (Panel 2)

Active Comparator group

Treatment:

Drug: BMS-816336

Drug: BMS-816336

Drug: BMS-816336

Drug: BMS-816336

Drug: Placebo

Drug: BMS-816336

BMS-816336 or placebo (Panel 3)

Active Comparator group

Treatment:

Drug: BMS-816336

Drug: BMS-816336

Drug: BMS-816336

Drug: BMS-816336

Drug: Placebo

Drug: BMS-816336

BMS-816336 or placebo (Panel 4)

Active Comparator group

Treatment:

Drug: BMS-816336

Drug: BMS-816336

Drug: BMS-816336

Drug: BMS-816336

Drug: Placebo

Drug: BMS-816336

BMS-816336 or placebo (Panel 5)

Active Comparator group

Treatment:

Drug: BMS-816336

Drug: BMS-816336

Drug: BMS-816336

Drug: BMS-816336

Drug: Placebo

Drug: BMS-816336