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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873415
• Other study ID #: IM011-019
• Status: Completed
• Phase: Phase 1
• Start date: January 25, 2019
• Est. completion date: May 1, 2019

Study information

• Verified date: November 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BMS-986165
Oral administration

Locations

Country	Name	City	State
United States	Scintipharma	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D		Determined over 5 days
Primary	Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D		Determined over 5 days
Primary	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
Primary	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
Primary	Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D		Determined over 5 days
Secondary	Vital signs of body temperature		Up to 60 days
Secondary	Pulse rate		Up to 60 days
Secondary	Physical examination		Up to 60 days
Secondary	Incidence of adverse events (AE)		Up to 90 days
Secondary	Incidence of serious adverse events (SAE)		Up to 90 days
Secondary	Vital sign of respiratory rate		Up to 60 days
Secondary	Vital sign of supine blood pressure		Up to 60 days

External Links

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