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

NCT03739788 | Completed Phase 1 FDA Drug

• 2 other identifiers: IM011-0672018-003134-33
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Absolute oral bioavailability (F) of BMS-986165 derived from plasma concentration versus time data

  4 days

Secondary Outcomes (3)

• 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

Study Arms (1)

BMS-986165

EXPERIMENTAL

Oral and intravenous administration

Drug: BMS-986165

Interventions

BMS-986165 DRUG

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

BMS-986165

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

Related Links

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

MeSH Terms

Interventions

deucravacitinib

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 14, 2018
• Study Start: December 5, 2018
• Primary Completion: February 11, 2019
• Study Completion: February 11, 2019
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

GB (1)