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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04008992
• Collaborator: (none)
• Enrollment: 132
• Locations: 2
• Arms: 13
• Actual Duration (Months): 18.6
• Patients Per Site: 66
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986259; Other: Placebo; Diagnostic Test: P-Aminohippurate; Diagnostic Test: Iohexol	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BMS-986259 in Healthy Participants.
• Actual Study Start Date: Jun 18, 2019
• Actual Primary Completion Date: Jan 4, 2021
• Actual Study Completion Date: Jan 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A SAD - A1 Cohort Single Ascending Dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part A SAD - A2 Cohort Single Ascending dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part A SAD- A3 Cohort Single Ascending dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part A SAD- A4 Cohort Single Ascending dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part A SAD - A5 Cohort Single Ascending dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part A SAD- A6 Cohort Single Ascending dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part B MAD- B1 Cohort Multiple Ascending Dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part B MAD - B2 Cohort Multiple Ascending Dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part B MAD - B3 Cohort Multiple Ascending Dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part B MAD - B4 Cohort Multiple Ascending Dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part C JMAD - C1 Cohort Japanese Multiple Ascending Dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part C JMAD - C2 Cohort Japanese Multiple Ascending Dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent
Experimental: Part C JMAD - C3 Cohort Japanese Multiple Ascending Dose	Drug: BMS-986259; Single and Multiple ascending dose from Dose 1 to Dose 5; Other: Placebo; Placebo matching BMS-986259; Diagnostic Test: P-Aminohippurate; Diagnostic Agent; Diagnostic Test: Iohexol; Diagnostic Agent

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events (AEs) [Up to 7 weeks]

2. Incidence of Serious Adverse Events (SAEs) [up to 7 weeks]

3. AEs leading to discontinuation [Up to 7 weeks]

4. Number of clinically significant changes in vital signs [Up to 7 weeks]

5. Number of clinically significant changes in ECG (electrocardiogram) [Up to 7 weeks]

6. Number of clinically significant changes in physical examinations [Up to 7 weeks]

7. Number of clinically significant changes in clinical laboratory tests [Up to 7 weeks]

Secondary Outcome Measures

1. Maximum observed concentration(Cmax)- Part A SAD [up to 7 weeks]

2. Time of maximum observed concentration(Tmax)- Part A SAD [Up to 7 weeks]

3. Terminal elimination rate constant (Lz)-Part A SAD [up to 7 weeks]

4. Half life (T-HALF)- Part A SAD [Up to 7 weeks]

5. 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]

6. Area under the concentration-time curve from time zero extrapolated to infinite time(AUC(INF)-Part A SAD [Up to 7 weeks]

7. Apparent total body clearance(CL/F)-Part A SAD [Up to 7 weeks]

8. Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD [Up to 7 weeks]

9. Maximum observed concentration(Cmax)-Part B and Part C MAD [Up to 7 years]

   For day 1 , day 13 and day 14

10. Time of maximum observed concentration(Tmax)-Part B and Part C MAD [Up tp 7 weeks]

    For day 1, day 13 and day 14

11. Area under the concentration-time curve in one dosing interval(AUC(TAU)- Part B and Part C MAD [Up to 7 weeks]

    For day 1 and day 14

12. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)-Part B and Part C MAD [Up to 7 weeks]

    For Day 14

13. Terminal elimination rate constant (Lz)-Part B and Part C MAD [up to 7 weeks]

    For day 14

14. Half life (T-HALF)- Part B and Part C MAD [Up to 7 weeks]

    For day 14

15. Apparent total body clearance(CL/F)-Part B and Part C MAD [Up to 7 weeks]

    For day 14

16. Apparent volume of distribution at terminal phase(Vz/F)- Part B and Part C MAD [Up to 7 weeks]

    For day 14

17. Accumulation Ratio Cmax (AR(Cmax)-Part B and Part C MAD [Up to 7 weeks]

    For day 14

18. Accumulation Ratio AUC(TAU) (AR(AUC[TAU])- Part B and Part C MAD [Up to 7 weeks]

    for day 14

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences - Groningen	Groningen		Netherlands	9728 NZ
2	Richmond Pharmacology	London		United Kingdom	SE1 1YR

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04008992
• Other Study ID Numbers: CV019-002
• First Posted: Jul 5, 2019
• Last Update Posted: Apr 9, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 9, 2021