Clinical trial NCT03245515: A Study of BMS-986195 in Healthy Male Subjects
Official title: Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-08-10
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 16 days
measure: Time to attain maximum observed plasma concentration (tmax)
timeFrame: Up to 16 days
measure: 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)]
timeFrame: Up to 16 days
measure: Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]
timeFrame: Up to 16 days
measure: Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)
timeFrame: Up to 16 days
measure: Terminal elimination rate constant (kel)
timeFrame: Up to 16 days
measure: Terminal elimination half life, calculated as 0.693/kel (t1/2)
timeFrame: Up to 16 days
measure: Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)
timeFrame: Up to 16 days
measure: Apparent volume of distribution at terminal phase (Vz/F)
timeFrame: Up to 16 days
measure: Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)
timeFrame: Up to 16 days
measure: Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
timeFrame: Up to 16 days
measure: Cumulative amount of TRA excreted in urine (Aeurine)
timeFrame: Up to 16 days
measure: Cumulative amount of TRA excreted in feces (Aefeces)
timeFrame: Up to 16 days
measure: Cumulative amount of TRA excreted in bile (Aebile)
timeFrame: Up to 16 days
measure: Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces
timeFrame: Up to 16 days
measure: Fraction of the dose administered excreted in urine (feurine)
timeFrame: Up to 16 days
measure: Fraction of the dose administered excreted in feces (fefeces)
timeFrame: Up to 16 days
measure: Fraction of the dose administered excreted in bile (febile)
timeFrame: Up to 16 days
measure: Fraction of the dose administered excreted in urine and feces (fetotal)
timeFrame: Up to 16 days
Secondary outcomes:
measure: Number of adverse events (AE)
timeFrame: Up to 16 days
measure: Number of serious adverse events (SAE)
timeFrame: Up to 16 days
measure: Number of laboratory test result abnormalities
timeFrame: Up to 16 days
measure: Heart rate measured by ECG
timeFrame: Up to 16 days
measure: PR-interval measured by ECG
timeFrame: Up to 16 days
measure: QRS-duration measured by ECG
timeFrame: Up to 16 days
measure: QT-interval measured by ECG
timeFrame: Up to 16 days
measure: QTc-interval (Fridericia's) measured by ECG
timeFrame: Up to 16 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: