Japanese Phase 1 Multiple Ascending Dose Study

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT01515202

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: BMS-823778 Drug: BMS-823778 Drug: BMS-823778 Drug: BMS-823778 Drug: Placebo matching with BMS-823778	Phase 1

Detailed Description

MAD study - Multiple Ascending Dose study

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Panel 1: BMS-823778 or Placebo matching BMS-823778 Healthy Subjects	Drug: BMS-823778 Capsules, Oral, 2 mg, Once daily, 14 days Drug: Placebo matching with BMS-823778 Capsules, Oral, 0 mg, Once daily, 14 days
Experimental: Panel 2: BMS-823778 or Placebo matching BMS-823778 Healthy Subjects	Drug: BMS-823778 Capsules, Oral, 12 mg, Once daily, 14 days Drug: Placebo matching with BMS-823778 Capsules, Oral, 0 mg, Once daily, 14 days
Experimental: Panel 3: BMS-823778 or Placebo matching BMS-823778 Healthy Subjects	Drug: BMS-823778 Capsules, Oral, 25 mg, Once daily, 14 days Drug: Placebo matching with BMS-823778 Capsules, Oral, 0 mg, Once daily, 14 days
Experimental: Panel 4: BMS-823778 or Placebo matching BMS-823778 Subjects with T2DM	Drug: BMS-823778 Capsules, Oral, 2 mg, Once daily, 14 days Drug: Placebo matching with BMS-823778 Capsules, Oral, 0 mg, Once daily, 14 days
Experimental: Panel 5: BMS-823778 or Placebo matching BMS-823778 Subjects with T2DM	Drug: BMS-823778 Capsules, Oral, 15 mg, Once daily, 14 days Drug: Placebo matching with BMS-823778 Capsules, Oral, 0 mg, Once daily, 14 days

Outcome Measures

Primary Outcome Measures

Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests [Up to Day 21]

Secondary Outcome Measures

Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration [Up to Day 21]
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) [Up to Day 21]
HPA = Hypothalamic-pituitary-adrenal DHEA-S = Dehydroepiandrosterone-sulphate ACTH = adrenocorticotropic hormone

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Hachioji-Shi	Tokyo	Japan	1920071

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01515202

Other Study ID Numbers:

MB121-009

First Posted:

Jan 24, 2012

Last Update Posted:

Dec 5, 2012

Last Verified:

Dec 1, 2012

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Dec 5, 2012