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Completed

NCT Number: NCT01515202

Japanese Phase 1 Multiple Ascending Dose Study

The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes Mellitus.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Hachioji-Shi, Tokyo, 1920071, Japan

About this study

MAD study - Multiple Ascending Dose study

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Japanese patients with Type 2 Diabetes Mellitus (T2DM) [Fasting glucose < 240 mg/dL, Hemoglobin A1c (HbA1c): 6.5% to 10.0% National Glycohemoglobin Standardization Program (NGSP)] who are treatment-naive and managed with diet and/or exercises only, ages: 20 to 65 years

Exclusion criteria

  • Patient who is taking any medication for T2DM
  • Symptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial
  • Insulin therapy within one year of screening

Treatment and study plan

BMS-823778

Drug

Capsules, Oral, 2 mg, Once daily, 14 days

Placebo matching with BMS-823778

Drug

Capsules, Oral, 0 mg, Once daily, 14 days

Primary outcomes

  1. Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests

    Time frame: Up to Day 21

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  2. Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  3. Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  4. Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  5. Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  6. Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  7. Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  8. Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  9. Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  10. Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  11. Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration

    Time frame: Up to Day 21

  12. Pharmacodynamics, as measured by Serum concentration of cortisol and cortisone after an oral dose of cortisone and biomarkers for HPA axis activity (urinary free cortisol and cortisone, salivary cortisol, ACTH, DHEA-S and 4-androstenedione)

    Time frame: Up to Day 21

    • HPA = Hypothalamic-pituitary-adrenal
    • DHEA-S = Dehydroepiandrosterone-sulphate
    • ACTH = adrenocorticotropic hormone

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled, Double-Blinded, Multiple Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-823778 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 24, 2012
Registry last updated
Dec 5, 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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