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)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01240980
First received: November 11, 2010
Last updated: March 14, 2012
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes |
Drug: BMS-903452 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments [ Time Frame: Within 10 days of study drug administration ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism [ Time Frame: Within 2 days of study drug administration ] [ Designated as safety issue: No ]
- Effect on electrocardiographic (ECG) parameters [ Time Frame: Within 10 days of study drug administration ] [ Designated as safety issue: Yes ]
- Percent urinary recovery (% UR) [ Time Frame: Within 10 days of study drug administration ] [ Designated as safety issue: No ]derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses
- Renal clearance (CLR) from plasma [ Time Frame: Within 10 days of study drug administration ] [ Designated as safety issue: No ]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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
| Enrollment: | 104 |
| Study Start Date: | November 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BMS-903452 (0.1 mg) or Placebo - A1
(Healthy Subjects)
|
Drug: BMS-903452
Solution, Oral, 0.1 mg, once daily, 1 day
Drug: Placebo
Solution, Oral, 0 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (0.6 mg) or Placebo - A2
(Healthy Subjects)
|
Drug: BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
Drug: Placebo
Solution, Oral, 0 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (3.0 mg) or Placebo - A3
(Healthy Subjects)
|
Drug: BMS-903452
Suspension, Oral, 3.0 mg, once daily, 1 day
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (10 mg) or Placebo - A4
(Healthy Subjects)
|
Drug: BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (30 mg) or Placebo - A5
(Healthy Subjects)
|
Drug: BMS-903452
Suspension, Oral, 30 mg, once daily, 1 day
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (60 mg) or Placebo - A6
(Healthy Subjects)
|
Drug: BMS-903452
Suspension, Oral, 60 mg, once daily, 1 day
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (120 mg) or Placebo - A7
(Healthy Subjects)
|
Drug: BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (0.6 mg) or Placebo - B1
(Subjects with type 2 Diabetes Mellitus)
|
Drug: Placebo
Solution, Oral, 0 mg, once daily, 1 day
Drug: BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (10 mg) or Placebo - B2
(Subjects with type 2 Diabetes Mellitus)
|
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
Drug: BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (120 mg) or Placebo - B3
(Subjects with type 2 Diabetes Mellitus)
|
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
Drug: BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (10 mg) or Placebo - A11
(Healthy Subjects)
|
Drug: BMS-903452
Suspension using crystalline form, Oral, 10 mg, once daily, 1 day
Drug: Placebo
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
|
|
Experimental: BMS-903452 (60 mg) or Placebo - A12
(Healthy Subjects)
|
Drug: BMS-903452
Suspension using crystalline form, Oral, 60 mg, once daily, 1 day
Drug: Placebo
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240980
Locations
| United States, Florida | |
| Comprehensive Phase One | |
| Miramar, Florida, United States, 33025 | |
| United States, Texas | |
| Ppd Development, Lp | |
| Austin, Texas, United States, 78744 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01240980 History of Changes |
| Other Study ID Numbers: | MB125-001 |
| Study First Received: | November 11, 2010 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013