An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

NCT03890809 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: IM011-0622018-002534-20
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 4

Brief Summary

The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.

Conditions

Liver Dysfunction; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Approximately 9 days

• Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]

  Approximately 9 days

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

  Approximately 9 days

Secondary Outcomes (2)

• Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation

  Approximately 44 days

• Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations

  Approximately 44 days

Study Arms (4)

Normal liver function

EXPERIMENTAL

Single dose

Drug: BMS-986165

Mild liver impairment

EXPERIMENTAL

Single dose

Drug: BMS-986165

Moderate liver impairment

EXPERIMENTAL

Single dose

Drug: BMS-986165

Severe liver impairment

EXPERIMENTAL

Single dose

Drug: BMS-986165

Interventions

BMS-986165 DRUG

Oral administration

Mild liver impairment; Moderate liver impairment; Normal liver function; Severe liver impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
• Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.73 m2 for participants

You may not qualify if:

• Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant
• History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening
• Have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (4)

Pharmaceutical Research Associates CZ, s.r.o

Prague, 170 00, Czechia

Location

Kenezy Gyula Korhaz es Rendelointezet

Debrecen, 4043, Hungary

Location

Clinical Research Unit Hungary

Miskolc, 3529, Hungary

Location

Local Institution

Bratislava, 831 01, Slovakia

Location

Related Links

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

MeSH Terms

Conditions

Liver Diseases

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 26, 2019
• Study Start: February 26, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: August 26, 2020

Record last verified: 2020-08

Locations

CZ (1); HU (2); SL (1)