A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT04464577
• Collaborator: (none)
• Enrollment: 0
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 2.2
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: Fluconazole; Drug: Bupropion; Drug: Itraconazole; Drug: BMS-986235	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-label Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Pharmacokinetics and Safety of BMS-986235
• Anticipated Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Jun 7, 2021
• Anticipated Study Completion Date: Jun 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: BMS-986235+Fluconazole	Drug: Fluconazole; Specified Dose on Specified Days; Drug: BMS-986235; Specified Dose on Specified Days
Experimental: Arm B: BMS-986235+ Bupropion	Drug: Bupropion; Specified Dose on Specified Days; Drug: BMS-986235; Specified Dose on Specified Days
Experimental: Arm C: BMS-986235+ Itraconazole	Drug: Itraconazole; Specified Dose on Specified Days; Drug: BMS-986235; Specified Dose on Specified Days

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole [Day 12]

2. Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole [Day 12]

3. Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole [Day 12]

4. Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion [Day 13]

5. Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion [Day 13]

6. Maximum plasma concentration (Cmax) of BMS-986235 with bupropion [Day 13]

7. Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole [Day 9]

8. Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole [Day 9]

9. Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole [Day 9]

10. Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 [Day 1]

11. Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 [Day 1]

12. Maximum plasma concentration (Cmax) of BMS-986235 [Day 1]

Secondary Outcome Measures

1. Incidence of Nonserious Adverse Events (AEs) [Up to 49 days]

2. Incidence of Serious Adverse Events (SAEs) [Up to 77 days]

3. Incidence of AEs leading to discontinuation [Up to 16 days]

4. Number of clinically significant changes from baseline in vital signs: Body Temperature [Up to 44 days]

5. Number of clinically significant changes from baseline in physical examinations [Up to 44 days]

6. Number of clinically significant changes in clinical laboratory tests: Hematology [Up to 44 days]

7. Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry [Up to 44 days]

8. Number of clinically significant changes in clinical laboratory tests: Coagulation [Up to 44 days]

9. Number of clinically significant changes in clinical laboratory tests: Urinalysis [Up to 44 days]

10. Number of clinically significant changes from baseline in vital signs: Respiratory Rate [Up to 44 days]

11. Number of clinically significant changes from baseline in vital signs: Heart Rate [Up to 44 days]

12. Number of clinically significant changes from baseline in vital signs:Blood Pressure [Up to 44 days]

13. Number of clinically significant changes in electrocardiogram (ECG) [Up to 44 days]

14. Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2)) [Up to 44 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.

• Males and females must agree to follow specific methods of contraception, if applicable.

• Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations, and no significant findings in medical history.

Exclusion Criteria:

• Women of childbearing potential (WOCBP), women who are pregnant or breastfeeding

• Inability to tolerate oral medication

• Known previous exposure to BMS-986235.

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Lenexa	Kansas	United States	66219
2	Local Institution	Salt Lake City	Utah	United States	84124

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: NCT04464577
• Other Study ID Numbers: CV018-014
• First Posted: Jul 9, 2020
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Itraconazole; Fluconazole; Bupropion

Study Results

No Results Posted as of Mar 25, 2022