A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.

NCT03890770 | Completed Phase 1 FDA Drug

• 2 other identifiers: IM011-0612018-002533-38
• Study Type: interventional
• Target: 44
• Locations: 4 countries
• Sites: 6

Brief Summary

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

Conditions

Renal Impairment; Healthy Volunteer

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 45 days

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

  Approximately 45 days

Study Arms (5)

Normal renal function

EXPERIMENTAL

Single dose

Drug: BMS-986165

Mild renal disease

EXPERIMENTAL

Single dose

Drug: BMS-986165

Moderate renal failure

EXPERIMENTAL

Single dose

Drug: BMS-986165

Severe renal failure

EXPERIMENTAL

Single dose

Drug: BMS-986165

End-stage renal disease requiring dialysis

EXPERIMENTAL

Two single doses administered with washout

Drug: BMS-986165

Interventions

BMS-986165 DRUG

Oral administration

End-stage renal disease requiring dialysis; Mild renal disease; Moderate renal failure; Normal renal function; Severe renal failure

Eligibility Criteria

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

You may qualify if:

• Participants must be judged to be in good health in the opinion of the investigator OR participant has a stable disease (eg, hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control (ie, no changes in medication within 30 days prior to study drug administration)
• Stable renal impairment, defined as no clinically significant change in disease status, as documented by the participant's most recent eGFR assessment; eGFR must not vary more than 30% from screening to Day -1 to confirm stable renal function, and the renal impairment must be expected by the investigator not to change significantly during the next 3 months
• Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥50 kg, at screening

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
• Have a history of cancer (malignancy) with the following exceptions: (1) subjects with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) subjects with other malignancies that 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
• History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (6)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Pharmaceutical Research Associates CZ, s.r.o

Prague, 170 00, Czechia

Location

Szent Imre Egyetemi Oktatokorhaz

Budapest, 1115, Hungary

Location

Kenezy Gyula Korhaz es Rendelointezet

Debrecen, 4043, Hungary

Location

Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II

Grodzisk Mazowiecki, 05-825, Poland

Location

Specjalistyczne Centrum Medyczne Chirurgii Maloinwazyjnej SCM

Krakow, 31-559, Poland

Location

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 26, 2019
• Study Start: April 4, 2019
• Primary Completion: February 7, 2020
• Study Completion: February 13, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

PL (2); HU (2); US (1); CZ (1)