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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04008992

CV019-002

Details and patient eligibility

About

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

Enrollment: 132 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.)

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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132 participants in 13 patient groups

Part A SAD - A1 Cohort

Experimental group

Description:

Single Ascending Dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part A SAD - A2 Cohort

Experimental group

Description:

Single Ascending dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part A SAD- A3 Cohort

Experimental group

Description:

Single Ascending dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part A SAD- A4 Cohort

Experimental group

Description:

Single Ascending dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part A SAD - A5 Cohort

Experimental group

Description:

Single Ascending dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part A SAD- A6 Cohort

Experimental group

Description:

Single Ascending dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part B MAD- B1 Cohort

Experimental group

Description:

Multiple Ascending Dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part B MAD - B2 Cohort

Experimental group

Description:

Multiple Ascending Dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part B MAD - B3 Cohort

Experimental group

Description:

Multiple Ascending Dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part B MAD - B4 Cohort

Experimental group

Description:

Multiple Ascending Dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part C JMAD - C1 Cohort

Experimental group

Description:

Japanese Multiple Ascending Dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part C JMAD - C2 Cohort

Experimental group

Description:

Japanese Multiple Ascending Dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol

Part C JMAD - C3 Cohort

Experimental group

Description:

Japanese Multiple Ascending Dose

Treatment:

Diagnostic Test: P-Aminohippurate

Other: Placebo

Drug: BMS-986259

Diagnostic Test: Iohexol