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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT03873415

Collaborator

(none)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: BMS-986165	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 25, 2019

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Formulation A Dosage formulation and area of release varies between arms	Drug: BMS-986165 Oral administration
Experimental: Formulation B Dosage formulation and area of release varies between arms	Drug: BMS-986165 Oral administration
Experimental: Formulation C Dosage formulation and area of release varies between arms	Drug: BMS-986165 Oral administration
Experimental: Formulation D Dosage formulation and area of release varies between arms	Drug: BMS-986165 Oral administration
Experimental: Formulation E Dosage formulation and area of release varies between arms	Drug: BMS-986165 Oral administration
Experimental: Formulation F Dosage formulation and area of release varies between arms	Drug: BMS-986165 Oral administration
Experimental: Formulation G Dosage formulation and area of release varies between arms	Drug: BMS-986165 Oral administration
Experimental: Formulation H Dosage formulation and area of release varies between arms	Drug: BMS-986165 Oral administration

Outcome Measures

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D [Determined over 5 days]
Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D [Determined over 5 days]
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 [Determined over 5 days]
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 [Determined over 5 days]
Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D [Determined over 5 days]

Secondary Outcome Measures

Vital signs of body temperature [Up to 60 days]
Pulse rate [Up to 60 days]
Physical examination [Up to 60 days]
Incidence of adverse events (AE) [Up to 90 days]
Incidence of serious adverse events (SAE) [Up to 90 days]
Vital sign of respiratory rate [Up to 60 days]
Vital sign of supine blood pressure [Up to 60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scintipharma	Lexington	Kentucky	United States	40504

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:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT03873415

Other Study ID Numbers:

IM011-019

First Posted:

Mar 13, 2019

Last Update Posted:

Nov 26, 2019

Last Verified:

Nov 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Psoriasis

BMS-986165

Study Results

No Results Posted as of Nov 26, 2019