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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04154800
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 5
• Actual Duration (Months): 20.8
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Health Participants	Drug: BMS-986209; Other: BMS-986209 Placebo; Drug: Itraconazole; Drug: Diltiazem	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Parts A,B,(Participant, Care Provider, Investigator) Part C is open-labeled and a cross- over design
• Primary Purpose: Treatment
• Official Title: A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986209 in Healthy Participants
• Actual Study Start Date: Dec 6, 2019
• Actual Primary Completion Date: Aug 31, 2021
• Actual Study Completion Date: Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A:SAD Single Ascending Dose	Drug: BMS-986209; Specified Dose on Specified Days
Experimental: Part B: MAD Multiple Ascending Dose	Drug: BMS-986209; Specified Dose on Specified Days
Experimental: Part C: DDI Drug-Drug Interaction	Drug: BMS-986209; Specified Dose on Specified Days; Drug: Itraconazole; Specified Dose on Specified Days; Drug: Diltiazem; Specified Dose on Specified Days
Experimental: Part A (SAD) Placebo	Other: BMS-986209 Placebo; Specified Dose on Specified Days
Experimental: Part B (MAD) Placebo	Other: BMS-986209 Placebo; Specified Dose on Specified Days

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events (AEs) including bleeding [Up to 18 days]

2. Incidence of serious AEs (SAEs) [Up to 44 days]

3. Incidence of AEs leading to discontinuation [Up to 18 days]

4. Incidence of clinically significant changes in vital signs: Body temperature [Up to 18 days]

5. Incidence of clinically significant changes in vital signs: Respiratory Rate [Up to 18 days]

6. Incidence of clinically significant changes in vital signs: Seated blood pressure [Up to 18 days]

7. Incidence of clinically significant changes in vital signs: Resting pulse rate [Up to 18 days]

8. Incidence of clinically significant changes in electrocardiogram (ECG) parameters [Up to 18 days]

9. Incidence of clinically significant changes in clinical laboratory tests: Hematology tests [Up to 16 days]

10. Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests [Up to 16 days]

11. Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests [Up to 16 days]

12. Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests [Up to 16 days]

13. Incidence of clinically significant changes in clinical laboratory tests: Serology tests [Up to 16 days]

Secondary Outcome Measures

1. Maximum observed plasma concentration (Cmax) of BMS-986209 [Up to 18 days]

2. Time of Maximum observed plasma concentration (Tmax) of BMS-986209 [Up to 18 days]

3. Terminal plasma half-life (T-Half) of BMS-986209 [Up to 18 days]

4. Incidence of Adverse Events (AEs) including bleeding [Up to 18 days]

5. Incidence of serious AEs (SAEs) [Up to 44 days]

6. Incidence of AEs leading to discontinuation [Up to 18 days]

7. Incidence of clinically significant changes in vital signs: Body temperature [Up to 18 days]

8. Incidence of clinically significant changes in vital signs: Respiratory Rate [Up to 18 days]

9. Incidence of clinically significant changes in vital signs: Seated blood pressure [Up to 18 days]

10. Incidence of clinically significant changes in vital signs: Resting pulse rate [Up to 18 days]

11. Incidence of clinically significant changes in electrocardiogram (ECG) parameters [Up to 18 days]

12. Incidence of clinically significant changes in clinical laboratory tests: Hematology tests [Up to 16 days]

13. Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests [Up to 16 days]

14. Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests [Up to 16 days]

15. Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests [Up to 16 days]

16. Incidence of clinically significant changes in clinical laboratory tests: Serology tests [Up to 16 days]

17. Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels [Up to 16 days]

18. Percent change from baseline in factor XI (FXI) clotting activity [Up to 16 days]

Eligibility Criteria

Criteria

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Development, LP	Austin	Texas	United States	78744

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04154800
• Other Study ID Numbers: CV017-003
• First Posted: Nov 7, 2019
• Last Update Posted: Jan 4, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Healthy Participants
• Additional relevant MeSH terms: Itraconazole; Diltiazem

Study Results

No Results Posted as of Jan 4, 2022