Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03930602
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 3
• Actual Duration (Days): 26
• Patients Per Site Per Month: 18.7

Study Details

Study Description

Brief Summary

To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BMS-986165; Drug: Fluvoxamine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Inhibition on the Pharmacokinetics of BMS-986165 in Healthy Participants
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: May 27, 2019
• Actual Study Completion Date: May 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986165+Fluvoxamine	Drug: BMS-986165; Participants will receive BMS-986165.; Drug: Fluvoxamine; Participants will receive fluvoxamine.
Experimental: BMS-986165 only	Drug: BMS-986165; Participants will receive BMS-986165.
Experimental: Fluvoxamine only	Drug: Fluvoxamine; Participants will receive fluvoxamine.

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) of BMS-986165 [10 days]

2. AUC(0-T) of BMS-986165 [10 days]

3. AUC(INF) of BMS-986165 [10 days]

Secondary Outcome Measures

1. Fluvoxamine steady-state plasma concentrations [10 days]

2. Percentage of participants with Adverse events (AEs) [From screening up to end of drug treatment (Day 13)]

3. Percentage of participants with Serious Adverse events (SAEs) and Death [From screening up to end of drug treatment (Day 13)]

4. Percentage of participants with Adverse events (AEs) leading to discontinutation [From screening up to end of drug treatment (Day 13)]

5. Percentage of participants with clinical significant laboratory abnormalities vital sign measurements and ECGs [From screening up to end of drug treatment (Day 13)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.

• Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.

• Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion Criteria:

• Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,

• Any major surgery within 4 weeks of study drug administration

• Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICON Plc (PRA Health Sciences)	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: NCT03930602
• Other Study ID Numbers: IM011-088
• First Posted: Apr 29, 2019
• Last Update Posted: Nov 17, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fluvoxamine; BMS-986165

Study Results

No Results Posted as of Nov 17, 2021