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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: BMS-986165

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Scintipharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

8

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2019
• Primary Completion (ACTUAL): May 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (ACTUAL): March 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; BMS-986165
• Other Study ID Numbers: IM011-019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No