Safety Study to Evaluate BMS-830216 in Healthy Subjects

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00878020
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 6
• Duration (Months): 4
• Patients Per Site Per Month: 11.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety profile, tolerability, and pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of BMS-819881) in healthy subjects

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: BMS-830216; Drug: Placebo; Drug: BMS-830216; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-830216 (Pro-Drug of BMS-819881) in Healthy Subjects
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 BMS-830216 (10 mg)	Drug: BMS-830216; Capsules, Oral, Single Dose, 1 day; Drug: Placebo; Capsules, Oral, 0mg, Single Dose, 1 day
Active Comparator: Arm 2 BMS-830216 (30 mg)	Drug: BMS-830216; Capsules, Oral, Single Dose, 1 day; Drug: Placebo; Capsules, Oral, 0mg, Single Dose, 1 day
Active Comparator: Arm 3 BMS-830216 (100 mg)	Drug: BMS-830216; Capsules, Oral, Single Dose, 1 day; Drug: Placebo; Capsules, Oral, 0mg, Single Dose, 1 day
Active Comparator: Arm 4 BMS-830216 (300 mg)	Drug: BMS-830216; Capsules, Oral, Single Dose on Day 1, Period 1 and Day 1, Period 2, 2 days; Drug: Placebo; Capsules, Oral, 0mg, Single Dose, on Day 1, Period 1 and Day 1, Period 2, 2 days
Active Comparator: Arm 5 BMS-830216 (600 mg)	Drug: BMS-830216; Capsules, Oral, Single Dose, 1 day; Drug: Placebo; Capsules, Oral, 0mg, Single Dose, 1 day
Active Comparator: Arm 6 BMS-830216 (1200 mg)	Drug: BMS-830216; Capsules, Oral, Single Dose, 1 day; Drug: Placebo; Capsules, Oral, 0mg, Single Dose, 1 day

Outcome Measures

Primary Outcome Measures

1. Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results [Within the 10 days after study drug administration]

Secondary Outcome Measures

1. Pharmacokinetic profile (drug absorption, distribution, metabolism and excretion process) determined by plasma concentration vs. time profile from a series of plasma samples up to 10 days post dose [Within the 10 days after study drug administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study

• Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men between ages of 18 to 45

Exclusion Criteria:

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ppd Development, Lp	Austin	Texas	United States	78744

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.

• ClinicalTrials.gov Identifier: NCT00878020
• Other Study ID Numbers: MB123-001
• First Posted: Apr 8, 2009
• Last Update Posted: Feb 23, 2011
• Last Verified: Nov 1, 2009

Study Results

No Results Posted as of Feb 23, 2011