NCT00836602
Completed
Phase 1
Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Atherosclerosis
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 in healthy subjects
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women (not of child bearing potential) ages 18 to 45
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria
- •Women of child bearing potential
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
Arms & Interventions
BMS-779788 or Placebo (Arm 1)
Intervention: Placebo
BMS-779788 or Placebo (Arm 2)
Intervention: BMS-779788
BMS-779788 or Placebo (Arm 2)
Intervention: Placebo
BMS-779788 or Placebo (Arm 1)
Intervention: BMS-779788
BMS-779788 or Placebo (Arm 3)
Intervention: BMS-779788
BMS-779788 or Placebo (Arm 3)
Intervention: Placebo
Outcomes
Primary Outcomes
Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Time Frame: 8 times within 27 days of the first dose
Secondary Outcomes
- Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)(After each dose panel)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in HealthyHealthy SubjectsOsteoarthritisNCT00380900Wyeth is now a wholly owned subsidiary of Pfizer
Completed
Phase 1
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese DescentHealthy ParticipantsNCT05546151Bristol-Myers Squibb24
Completed
Phase 1
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus ParticipantsLupus Erythematosus, SystemicNCT05278663Eisai Co., Ltd.26
Terminated
Phase 1
Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine SubjectsMigraineNCT02132429Amgen16
Completed
Phase 1
GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy SubjectsHealthyNCT00989703Galapagos NV24