Japanese Phase 1 Multiple Ascending Dose Study

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515202
• Other study ID #: MB121-009
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2012
• Last updated: December 4, 2012
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Description:

MAD study - Multiple Ascending Dose study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• BMS-823778
Capsules, Oral, 2 mg, Once daily, 14 days
• BMS-823778
Capsules, Oral, 12 mg, Once daily, 14 days
• BMS-823778
Capsules, Oral, 25 mg, Once daily, 14 days
• BMS-823778
Capsules, Oral, 15 mg, Once daily, 14 days
• Placebo matching with BMS-823778
Capsules, Oral, 0 mg, Once daily, 14 days

Locations

Country	Name	City	State
Japan	Local Institution	Hachioji-Shi	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration		Up to Day 21	No
Secondary	Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration		Up to Day 21	No
Secondary	Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration		Up to Day 21	No
Secondary	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	No
Secondary	Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration		Up to Day 21	No
Secondary	Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration		Up to Day 21	No
Secondary	Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration		Up to Day 21	No
Secondary	Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration		Up to Day 21	No
Secondary	Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration		Up to Day 21	No
Secondary	Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration		Up to Day 21	No
Secondary	Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration		Up to Day 21	No
Secondary	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)	HPA = Hypothalamic-pituitary-adrenal; DHEA-S = Dehydroepiandrosterone-sulphate; ACTH = adrenocorticotropic hormone	Up to Day 21	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form