A Study of BMS-986195 in Healthy Male Subjects

Rheumatoid Arthritis Clinical Trial

Official title:

Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245515
• Other study ID #: IM014-016
• Secondary ID: 2017-002706-12
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2017
• Last updated: January 3, 2018
• Start date: August 15, 2017
• Est. completion date: October 5, 2017

Study information

• Verified date: January 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 5, 2017
• Est. primary completion date: September 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Inclusion Criteria:

• Male subjects, if not surgically sterilized, must agree to use adequate contraception

• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight [kg]/[height (m)]2), and total body weight >50 kg

• All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center

• All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center

• Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center

• Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the Principal Investigator

Exclusion Criteria:

• Previous participation in the current study

• Known previous exposure to BMS-986195

• Employee of PRA or the Sponsor

• History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products

• Using tobacco products within 60 days prior to drug administration

• Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BMS-986195
specified dose on specified days

Locations

Country	Name	City	State
Netherlands	Local Institution	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Up to 16 days
Primary	Time to attain maximum observed plasma concentration (tmax)		Up to 16 days
Primary	Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation [AUC(t-0)]		Up to 16 days
Primary	Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Clast/kel [AUC(0-inf)]		Up to 16 days
Primary	Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)		Up to 16 days
Primary	Terminal elimination rate constant (kel)		Up to 16 days
Primary	Terminal elimination half life, calculated as 0.693/kel (t1/2)		Up to 16 days
Primary	Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)		Up to 16 days
Primary	Apparent volume of distribution at terminal phase (Vz/F)		Up to 16 days
Primary	Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)		Up to 16 days
Primary	Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)		Up to 16 days
Primary	Cumulative amount of TRA excreted in urine (Aeurine)		Up to 16 days
Primary	Cumulative amount of TRA excreted in feces (Aefeces)		Up to 16 days
Primary	Cumulative amount of TRA excreted in bile (Aebile)		Up to 16 days
Primary	Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces		Up to 16 days
Primary	Fraction of the dose administered excreted in urine (feurine)		Up to 16 days
Primary	Fraction of the dose administered excreted in feces (fefeces)		Up to 16 days
Primary	Fraction of the dose administered excreted in bile (febile)		Up to 16 days
Primary	Fraction of the dose administered excreted in urine and feces (fetotal)		Up to 16 days
Secondary	Number of adverse events (AE)		Up to 16 days
Secondary	Number of serious adverse events (SAE)		Up to 16 days
Secondary	Number of laboratory test result abnormalities		Up to 16 days
Secondary	Heart rate measured by ECG		Up to 16 days
Secondary	PR-interval measured by ECG		Up to 16 days
Secondary	QRS-duration measured by ECG		Up to 16 days
Secondary	QT-interval measured by ECG		Up to 16 days
Secondary	QTc-interval (Fridericia's) measured by ECG		Up to 16 days

External Links

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