Clinical trial NCT01515202: Japanese Phase 1 Multiple Ascending Dose Study
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
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 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.

Detailed description: MAD study - Multiple Ascending Dose study

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
timeFrame: Up to Day 21
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration
timeFrame: Up to Day 21
measure: 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)
timeFrame: Up to Day 21
Other outcomes:
Locations:
city: Hachioji-Shi
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: