A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants

NCT04154800 | Completed Phase 1 FDA Drug

• 1 other identifier: CV017-003
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect.

Conditions

Health Participants

Keywords

Healthy Participants

Outcome Measures

Primary Outcomes (13)

• Incidence of Adverse Events (AEs) including bleeding

  Up to 18 days

• Incidence of serious AEs (SAEs)

  Up to 44 days

• Incidence of AEs leading to discontinuation

  Up to 18 days

• Incidence of clinically significant changes in vital signs: Body temperature

  Up to 18 days

• Incidence of clinically significant changes in vital signs: Respiratory Rate

  Up to 18 days

• Incidence of clinically significant changes in vital signs: Seated blood pressure

  Up to 18 days

• Incidence of clinically significant changes in vital signs: Resting pulse rate

  Up to 18 days

• Incidence of clinically significant changes in electrocardiogram (ECG) parameters

  Up to 18 days

• Incidence of clinically significant changes in clinical laboratory tests: Hematology tests

  Up to 16 days

• Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests

  Up to 16 days

• Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests

  Up to 16 days

• Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests

  Up to 16 days

• Incidence of clinically significant changes in clinical laboratory tests: Serology tests

  Up to 16 days

Secondary Outcomes (18)

• Maximum observed plasma concentration (Cmax) of BMS-986209

  Up to 18 days

• Time of Maximum observed plasma concentration (Tmax) of BMS-986209

  Up to 18 days

• Terminal plasma half-life (T-Half) of BMS-986209

  Up to 18 days

• Incidence of Adverse Events (AEs) including bleeding

  Up to 18 days

• Incidence of serious AEs (SAEs)

  Up to 44 days

Study Arms (5)

Part A:SAD

EXPERIMENTAL

Single Ascending Dose

Drug: BMS-986209

Part B: MAD

EXPERIMENTAL

Multiple Ascending Dose

Drug: BMS-986209

Part C: DDI

EXPERIMENTAL

Drug-Drug Interaction

Drug: BMS-986209; Drug: Itraconazole; Drug: Diltiazem

Part A (SAD) Placebo

EXPERIMENTAL

Other: BMS-986209 Placebo

Part B (MAD) Placebo

EXPERIMENTAL

Other: BMS-986209 Placebo

Interventions

BMS-986209 DRUG

Specified Dose on Specified Days

Part A:SAD; Part B: MAD; Part C: DDI

BMS-986209 Placebo OTHER

Specified Dose on Specified Days

Part A (SAD) Placebo; Part B (MAD) Placebo

Itraconazole DRUG

Specified Dose on Specified Days

Part C: DDI

Diltiazem DRUG

Specified Dose on Specified Days

Part C: DDI

Eligibility Criteria

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

You may qualify if:

• Healthy male and female participants (not of childbearing potential) as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations
• Women and men must agree to follow specific methods of contraception if applicable.
• Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants

You may not qualify if:

• Women who are of childbearing potential
• Women who are breastfeeding
• Any acute or chronic medical illness
• History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study treatment administration)
• History of heart disease or conduction disorders
• Head injury in the last 2 years, intracranial tumor, or aneurysm
• Known abdominal aneurysm
• Current or history of rectal bleeding, hematemesis, or hematuria

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

Related Links

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

MeSH Terms

Interventions

Itraconazole; Diltiazem

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Parts A,B,(Participant, Care Provider, Investigator) Part C is open-labeled and a cross- over design
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: December 6, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Locations

US (1)