An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants

NCT04008992 | Completed Phase 1

• 1 other identifier: CV019-002
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 2

Brief Summary

A Randomized double blind, placebo controlled study of BMS-986259 to evaluate the safety and effectiveness of the drug amongst different conditions and populations.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (7)

• Incidence of Adverse Events (AEs)

  Up to 7 weeks

• Incidence of Serious Adverse Events (SAEs)

  up to 7 weeks

• AEs leading to discontinuation

  Up to 7 weeks

• Number of clinically significant changes in vital signs

  Up to 7 weeks

• Number of clinically significant changes in ECG (electrocardiogram)

  Up to 7 weeks

• Number of clinically significant changes in physical examinations

  Up to 7 weeks

• Number of clinically significant changes in clinical laboratory tests

  Up to 7 weeks

Secondary Outcomes (18)

• Maximum observed concentration(Cmax)- Part A SAD

  up to 7 weeks

• Time of maximum observed concentration(Tmax)- Part A SAD

  Up to 7 weeks

• Terminal elimination rate constant (Lz)-Part A SAD

  up to 7 weeks

• Half life (T-HALF)- Part A SAD

  Up to 7 weeks

• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)- Part A SAD

  Up to 7 weeks

Study Arms (13)

Part A SAD - A1 Cohort

EXPERIMENTAL

Single Ascending Dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part A SAD - A2 Cohort

EXPERIMENTAL

Single Ascending dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part A SAD- A3 Cohort

EXPERIMENTAL

Single Ascending dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part A SAD- A4 Cohort

EXPERIMENTAL

Single Ascending dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part A SAD - A5 Cohort

EXPERIMENTAL

Single Ascending dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part A SAD- A6 Cohort

EXPERIMENTAL

Single Ascending dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part B MAD- B1 Cohort

EXPERIMENTAL

Multiple Ascending Dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part B MAD - B2 Cohort

EXPERIMENTAL

Multiple Ascending Dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part B MAD - B3 Cohort

EXPERIMENTAL

Multiple Ascending Dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part B MAD - B4 Cohort

EXPERIMENTAL

Multiple Ascending Dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part C JMAD - C1 Cohort

EXPERIMENTAL

Japanese Multiple Ascending Dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part C JMAD - C2 Cohort

EXPERIMENTAL

Japanese Multiple Ascending Dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Part C JMAD - C3 Cohort

EXPERIMENTAL

Japanese Multiple Ascending Dose

Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol

Interventions

BMS-986259 DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Part A SAD - A1 Cohort; Part A SAD - A2 Cohort; Part A SAD - A5 Cohort; Part A SAD- A3 Cohort; Part A SAD- A4 Cohort; Part A SAD- A6 Cohort; Part B MAD - B2 Cohort; Part B MAD - B3 Cohort; Part B MAD - B4 Cohort; Part B MAD- B1 Cohort; Part C JMAD - C1 Cohort; Part C JMAD - C2 Cohort; Part C JMAD - C3 Cohort

Placebo OTHER

Placebo matching BMS-986259

Part A SAD - A1 Cohort; Part A SAD - A2 Cohort; Part A SAD - A5 Cohort; Part A SAD- A3 Cohort; Part A SAD- A4 Cohort; Part A SAD- A6 Cohort; Part B MAD - B2 Cohort; Part B MAD - B3 Cohort; Part B MAD - B4 Cohort; Part B MAD- B1 Cohort; Part C JMAD - C1 Cohort; Part C JMAD - C2 Cohort; Part C JMAD - C3 Cohort

P-Aminohippurate DIAGNOSTIC_TEST

Diagnostic Agent

Part A SAD - A1 Cohort; Part A SAD - A2 Cohort; Part A SAD - A5 Cohort; Part A SAD- A3 Cohort; Part A SAD- A4 Cohort; Part A SAD- A6 Cohort; Part B MAD - B2 Cohort; Part B MAD - B3 Cohort; Part B MAD - B4 Cohort; Part B MAD- B1 Cohort; Part C JMAD - C1 Cohort; Part C JMAD - C2 Cohort; Part C JMAD - C3 Cohort

Iohexol DIAGNOSTIC_TEST

Diagnostic Agent

Part A SAD - A1 Cohort; Part A SAD - A2 Cohort; Part A SAD - A5 Cohort; Part A SAD- A3 Cohort; Part A SAD- A4 Cohort; Part A SAD- A6 Cohort; Part B MAD - B2 Cohort; Part B MAD - B3 Cohort; Part B MAD - B4 Cohort; Part B MAD- B1 Cohort; Part C JMAD - C1 Cohort; Part C JMAD - C2 Cohort; Part C JMAD - C3 Cohort

Eligibility Criteria

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

You may qualify if:

• Healthy participants with a body mass Index (BMI) of 18.0 kg/m\^2 - 30.0 kg/m\^2.
• Males and females not of child bearing potential.
• Participants in the Japanese Cohorts in Part C must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese.)

You may not qualify if:

• Any previous dosing in another cohort in the current study or participation in an investigational drug within 2 months prior to (the first) drug administration in the current study.
• Any Significant Acute or Chronic medical Illness, major surgery in 12 months, or so smoking or used smoking cessation in 3 months.
• Inability to be venipunctured and/or tolerate venous access. ,abnormalities in hemoglobin or positive screen for hepatitis C, Hepatitis B, Human Immunodeficiency Virus (HIV), including hepatic disease

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

PRA Health Sciences - Groningen

Groningen, 9728 NZ, Netherlands

Location

Richmond Pharmacology

London, SE1 1YR, United Kingdom

Location

Related Links

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: July 5, 2019
• Study Start: June 18, 2019
• Primary Completion: January 4, 2021
• Study Completion: January 4, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

NL (1); GB (1)