Wcct Global, Llc
Cypress, California, 90630, United States
NCT Number: NCT03142165
The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Cypress, California, 90630, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion criteria
Exclusion criteria
Other protocol defined inclusion/exclusion criteria could apply
3 weekly doses of 90 mg infused intravenous administration
Placebo
50 mg intravenous administration
20 mg intravenous administration
Time frame: 28 days
measured by incidences
Time frame: 30 days
measured by incidences
Time frame: 28 days
measured by incidences
Time frame: 28 days
measured by incidences
Time frame: 28 days
measured by incidences
Time frame: 28 days
measured by incidences
Time frame: 28 days
measured by incidences
Time frame: 28 days
Maximum observed plasma concentration
Time frame: 28 days
Time of maximum observed plasma concentration
Time frame: 28 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration
Time frame: 28 days
Area under the concentration-time curve in one dosing interval (multiple dose only)
Time frame: 28 days
Terminal phase half-life
Time frame: 28 days
Total body clearance after IV dose
Time frame: 28 days
Accumulation Index, the ratio of AUC(TAU) at steady-state to that after the first dose (Day 15 only)
Time frame: 28 days
Effective elimination half-life that explains the degree of accumulation observed for AUC(TAU) (Day 15 only)
Time frame: 28 days
Trough observed plasma concentration
Time frame: 28 days
Investigation of population specific differences in PK
Bristol-Myers Squibb
Industry
A Randomized, Placebo-Controlled, Double-Blind, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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