An Investigational Study to Determine the Drug Level Prof... | NCT04086719

Studies
An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.

NCT04086719

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Aug 5, 2020Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

Healthy Male Volunteers

Interventions

BMS-986165
Pyrimethamine

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

Aug 2020

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

Sep 12, 2019Actual

Primary Completion Date

Oct 29, 2019Actual

Completion Date

Oct 29, 2019Actual

First Submitted Date

Sep 10, 2019

First Submission Date that Met QC Criteria

Sep 10, 2019

First Posted Date

Sep 12, 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

Aug 3, 2020

Last Update Posted Date

Aug 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

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	Description	Intervention Names
BMS- 986185 + Pyrimethamine	Experimental		Drug: Pyrimethamine
BMS-986185	Experimental		Drug: BMS-986165

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986165	Drug	Oral administration of tablet BMS- 986165	BMS-986185

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed serum comcentration (Cmax)		Day 1, Day 5
Area under the concentration-time curve from time zero extrapolated to AUC(INF)		Day 1, Day 5

Secondary Outcomes

Measure	Description	Time Frame
Incidences of Adverse Events (AE's)		Approximetly 20 days
Time of maximum observed concentration (Tmax)		Approxmiately 20 days
Half- life time (T-Half)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be willing and able to complete all study-specific procedures and visits
Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
Normal renal function at screening

Exclusion Criteria:

Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
Additional criteria may apply

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PRA Health Sciences - Salt Lake		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
D011739	Pyrimethamine

ID	Term
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds