An Investigational Study to Evaluate Experimental Medication BMS-986165 Given as a Tablet and Solution in Healthy Male Participants

Healthy Participants Clinical Trial

Official title:

Study to Evaluate the Absolute Bioavailability of BMS-986165 Tablet in Healthy Male Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739788
• Other study ID #: IM011-067
• Secondary ID: 2018-003134-33
• Status: Completed
• Phase: Phase 1
• Start date: December 5, 2018
• Est. completion date: February 11, 2019

Study information

• Verified date: February 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate BMS-986165 given as a tablet in healthy male participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 11, 2019
• Est. primary completion date: February 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Inclusion Criteria:

• Healthy male participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight = 50 kg (110 lb). BMI = weight (kg)/(height [m])2 at screening

• Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) = 80 mL/min/1.732

Exclusion Criteria:

• Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease

• Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug

• History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986165
Oral administration of tablet and 15-minute intravenous BMS-986165 solution for infusion

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute oral bioavailability (F) of BMS-986165 derived from plasma concentration versus time data		4 days
Secondary	Incidence of nonserious adverse events (AE)		Up to 34 days
Secondary	Incidence of serious adverse events (SAE)		Up to 34 days
Secondary	Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory tests		Up to 34 days

External Links

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