Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

Healthy Participants Clinical Trial

Official title:

A Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249284
• Other study ID #: IM011-096
• Status: Completed
• Phase: Phase 1
• Start date: February 6, 2020
• Est. completion date: March 15, 2020

Study information

• Verified date: April 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations.

• Body weight >= 50 kg at screening

• Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

• Any major surgery, per investigator's discretion, within 4 weeks of study drug administration

• Inability to tolerate oral medication

• History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986165
Specified dose on specified days
• BMS-986165 prototype 1
Specified dose on specified days
• BMS-986165 prototype 2
Specified dose on specified days

Locations

Country	Name	City	State
United States	Quotient Sciences Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax) for BMS-986165 in plasma		Up to 18 days
Primary	Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma		Up to 18 days
Primary	Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma		Up to 18 days
Secondary	Incidence of Adverse Events (AEs)		Up to 23 days
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 55 days
Secondary	Number of clinically significant abnormalities in electrocardiogram (ECG) parameters		Up to 50 days
Secondary	Number of participants with vital sign abnormalities in body temperature		Up to 50 days
Secondary	Number of participants with vital sign abnormalities in respiratory rate		Up to 50 days
Secondary	Number of participants with vital sign abnormalities in heart rate		Up to 50 days
Secondary	Number of participants with vital sign abnormalities in blood pressure		Up to 50 days
Secondary	Number of participants with clinical laboratory test abnormalities: Hematology tests		Up to 50 days
Secondary	Number of participants with clinical laboratory test abnormalities: Clinical chemistry tests		Up to 50 days
Secondary	Number of participants with clinical laboratory test abnormalities: Urinalysis tests		Up to 50 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form