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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03739788

Enrollment

Registered

2018-11-14

Start date

2018-12-05

Completion date

2019-02-11

Last updated

2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief summary

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

Interventions

DRUGBMS-986165

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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/

Design outcomes

Primary

Measure	Time frame
Absolute oral bioavailability (F) of BMS-986165 derived from plasma concentration versus time data	4 days

Secondary

Measure	Time frame
Incidence of nonserious adverse events (AE)	Up to 34 days
Incidence of serious adverse events (SAE)	Up to 34 days
Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory tests	Up to 34 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026