NCT03197779

A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS- 962212 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 691 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics following increasing doses of 2 h (Part A) and 5 day (Part B) continuous IV infusions of BMS-962212 in healthy subjects across the expected pharmacodynamic dose range.

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	BMS-962212	Intravenous Infusion administration over 2 hours or 5 days
DRUG	Aspirin	Oral administration
OTHER	Placebo	Oral administration

Timeline

• Start date: 2013-11-18
• Primary completion: 2016-02-02
• Completion: 2017-01-24
• First posted: 2017-06-23
• Last updated: 2017-07-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study