Clinical trial NCT01240980: Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & 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)
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-903452 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
timeFrame: Within 10 days of study drug administration
Secondary outcomes:
measure: Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism
timeFrame: Within 2 days of study drug administration
measure: Effect on electrocardiographic (ECG) parameters
timeFrame: Within 10 days of study drug administration
measure: Percent urinary recovery (% UR)
timeFrame: Within 10 days of study drug administration
measure: Renal clearance (CLR) from plasma
timeFrame: Within 10 days of study drug administration
measure: The single-dose pharmacokinetics parameter maximum observed concentration in plasma (Cmax) of BMS-903452 will be derived from the plasma concentration versus time data
timeFrame: Within 10 days after study drug administration
measure: 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
timeFrame: Within 10 days after study drug administration
measure: 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
timeFrame: Within 10 days after study drug administration
measure: 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
timeFrame: Within 10 days after study drug administration
measure: 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
timeFrame: Within 10 days after study drug administration
measure: 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
timeFrame: Within 10 days after study drug administration
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Comprehensive Phase One
state: Florida
city: Austin
country: United States
facility: Ppd Development, Lp
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: