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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03739788
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.2
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986165	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study to Evaluate the Absolute Bioavailability of BMS-986165 Tablet in Healthy Male Participants
• Actual Study Start Date: Dec 5, 2018
• Actual Primary Completion Date: Feb 11, 2019
• Actual Study Completion Date: Feb 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986165 Oral and intravenous administration	Drug: BMS-986165; Oral administration of tablet and 15-minute intravenous BMS-986165 solution for infusion

Outcome Measures

Primary Outcome Measures

1. Absolute oral bioavailability (F) of BMS-986165 derived from plasma concentration versus time data [4 days]

Secondary Outcome Measures

1. Incidence of nonserious adverse events (AE) [Up to 34 days]

2. Incidence of serious adverse events (SAE) [Up to 34 days]

3. Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory tests [Up to 34 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Sciences	Nottingham		United Kingdom	NG11 6JS

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03739788
• Other Study ID Numbers: IM011-067; 2018-003134-33
• First Posted: Nov 14, 2018
• Last Update Posted: Feb 26, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: BMS-986165

Study Results

No Results Posted as of Feb 26, 2021