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Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-986165

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Inclusion Criteria:

Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
Estimated glomerular filtration rate (eGFR) > 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula

Exclusion Criteria:

Any significant acute or chronic medical illness
Current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug
Acute diarrhea, or constipation within 3 weeks prior to randomization
Any major surgery within 4 weeks of randomization

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

Scintipharma

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Formulation A

Formulation B

Formulation C

Formulation D

Formulation E

Formulation F

Formulation G

Formulation H

Arm Description

Dosage formulation and area of release varies between arms

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D

Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D

Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D

Secondary Outcome Measures

Vital signs of body temperature

Pulse rate

Physical examination

Incidence of adverse events (AE)

Incidence of serious adverse events (SAE)

Vital sign of respiratory rate

Vital sign of supine blood pressure

Full Information

NCT ID

NCT03873415

First Posted

February 4, 2019

Last Updated

November 25, 2019

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03873415

Brief Title

Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males

Official Title

Assessment of Regional Gastrointestinal Absorption of BMS-986165 Using Pharmacoscintigraphic Evaluation in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

January 25, 2019 (Actual)

Primary Completion Date

May 1, 2019 (Actual)

Study Completion Date

May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Formulation A

Arm Type

Experimental

Arm Description

Dosage formulation and area of release varies between arms

Arm Title

Formulation B

Arm Type

Experimental

Arm Description

Dosage formulation and area of release varies between arms

Arm Title

Formulation C

Arm Type

Experimental

Arm Description

Dosage formulation and area of release varies between arms

Arm Title

Formulation D

Arm Type

Experimental

Arm Description

Dosage formulation and area of release varies between arms

Arm Title

Formulation E

Arm Type

Experimental

Arm Description

Dosage formulation and area of release varies between arms

Arm Title

Formulation F

Arm Type

Experimental

Arm Description

Dosage formulation and area of release varies between arms

Arm Title

Formulation G

Arm Type

Experimental

Arm Description

Dosage formulation and area of release varies between arms

Arm Title

Formulation H

Arm Type

Experimental

Arm Description

Dosage formulation and area of release varies between arms

Intervention Type

Drug

Intervention Name(s)

BMS-986165

Intervention Description

Oral administration

Primary Outcome Measure Information:

Title

Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D

Time Frame

Determined over 5 days

Title

Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D

Time Frame

Determined over 5 days

Title

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D

Time Frame

Determined over 5 days

Title

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D

Time Frame

Determined over 5 days

Title

Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D

Time Frame

Determined over 5 days

Secondary Outcome Measure Information:

Title

Vital signs of body temperature

Time Frame

Up to 60 days

Title

Pulse rate

Time Frame

Up to 60 days

Title

Physical examination

Time Frame

Up to 60 days

Title

Incidence of adverse events (AE)

Time Frame

Up to 90 days

Title

Incidence of serious adverse events (SAE)

Time Frame

Up to 90 days

Title

Vital sign of respiratory rate

Time Frame

Up to 60 days

Title

Vital sign of supine blood pressure

Time Frame

Up to 60 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening Estimated glomerular filtration rate (eGFR) > 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula Exclusion Criteria: Any significant acute or chronic medical illness Current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug Acute diarrhea, or constipation within 3 weeks prior to randomization Any major surgery within 4 weeks of randomization Other protocol defined inclusion/exclusion criteria could apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Scintipharma

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males

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