Safety Study to Evaluate BMS-830216 in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00878020

Enrollment

Registered

2009-04-08

Start date

2009-05-31

Completion date

2009-09-30

Last updated

2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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

Interventions

DRUGBMS-830216

Capsules, Oral, Single Dose, 1 day

DRUGPlacebo

Capsules, Oral, 0mg, Single Dose, 1 day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results	Within the 10 days after study drug administration

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026