Diabetes
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of BMS-903452 compared to placebo in healthy subjects & relative bioavailability of the crystalline and amorphous forms of BMS-903452 \[Panels 4,6,11 & 12(Part A)\] ; and subjects with type 2 Diabetes Mellitus (Part B). The study will also determine the amount of BMS-903452 in the blood.
Interventions
DRUGBMS-903452
Solution, Oral, 0.1 mg, once daily, 1 day
DRUGPlacebo
Solution, Oral, 0 mg, once daily, 1 day
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinically healthy or Clinical diagnosis of Type 2 diabetes on a stable dose of metformin monotherapy
Exclusion criteria
* Type 1 Diabetes * History of significant heart disease * Prior bariatric surgery * Women of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments | Within 10 days of study drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on electrocardiographic (ECG) parameters | Within 10 days of study drug administration | — |
| Percent urinary recovery (% UR) | Within 10 days of study drug administration | derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses |
| Renal clearance (CLR) from plasma | Within 10 days of study drug administration | derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses |
| The single-dose pharmacokinetics parameter maximum observed concentration in plasma (Cmax) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration | — |
| Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism | Within 2 days of study drug administration | — |
| The single-dose pharmacokinetics parameter time Area under the plasma concentration-time curve from time zero extrapolated to infinity AUC(INF) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration | — |
| The single-dose pharmacokinetics parameter Area under the plasma concentration-time curve from time zero to last measurable sampling time AUC (0-T) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration | — |
| The single-dose pharmacokinetics parameter Terminal-phase elimination half-life in plasma (T-Half) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration | — |
| The single-dose pharmacokinetics parameter apparent clearance from plasma after extra-vascular administration (CLT/F) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration | — |
| The single-dose pharmacokinetics parameter time to reach maximum observed concentration in plasma (Tmax) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration | — |
Countries
United States
Outcome results
None listed