Study to Characterize the Effects of Cytochrome p450 1A2... | NCT03930602

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

NCT03930602

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Nov 17, 2021Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

Healthy

Interventions

BMS-986165
Fluvoxamine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

May 27, 2019Actual

Completion Date

May 27, 2019Actual

First Submitted Date

Apr 26, 2019

First Submission Date that Met QC Criteria

Apr 26, 2019

First Posted Date

Apr 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2021

Last Update Posted Date

Nov 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
BMS-986165+Fluvoxamine	Experimental	Drug: BMS-986165 Drug: Fluvoxamine
BMS-986165 only	Experimental	Drug: BMS-986165
Fluvoxamine only	Experimental	Drug: Fluvoxamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986165	Drug	Participants will receive BMS-986165.	BMS-986165 only BMS-986165+Fluvoxamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed plasma concentration (Cmax) of BMS-986165		10 days
AUC(0-T) of BMS-986165		10 days
AUC(INF) of BMS-986165		10 days

Secondary Outcomes

Measure	Description	Time Frame
Fluvoxamine steady-state plasma concentrations		10 days
Percentage of participants with Adverse events (AEs)		From screening up to end of drug treatment (Day 13)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ICON Plc (PRA Health Sciences)		Salt Lake City	Utah	84124	United States

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
Investigator Inquiry Form

ID	Term
C000628674	deucravacitinib
D016666	Fluvoxamine

ID	Term
D010091	Oximes
D006898	Hydroxylamines
D000588	Amines
D009930	Organic Chemicals