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NCT Number: 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)

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Comprehensive Phase One, Miramar, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-903452

Drug

Solution, Oral, 0.1 mg, once daily, 1 day

Placebo

Drug

Solution, Oral, 0 mg, once daily, 1 day

Primary outcomes

  1. 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

Secondary outcomes

  1. Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism

    Time frame: Within 2 days of study drug administration

  2. Effect on electrocardiographic (ECG) parameters

    Time frame: Within 10 days of study drug administration

  3. Percent urinary recovery (% UR)

    Time frame: 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

  4. Renal clearance (CLR) from plasma

    Time frame: 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 15, 2010
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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