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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03245515 |
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Date of registration:
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08/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of BMS-986195 in Healthy Male Subjects
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Scientific title:
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Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects |
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Date of first enrolment:
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August 15, 2017 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03245515 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: BMS-986195
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Primary Outcome(s)
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Apparent volume of distribution at terminal phase (Vz/F)
[Time Frame: Up to 16 days]
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Cumulative amount of TRA excreted in urine (Aeurine)
[Time Frame: Up to 16 days]
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Fraction of the dose administered excreted in urine (feurine)
[Time Frame: Up to 16 days]
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Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)
[Time Frame: Up to 16 days]
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Cumulative amount of TRA excreted in bile (Aebile)
[Time Frame: Up to 16 days]
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Fraction of the dose administered excreted in bile (febile)
[Time Frame: Up to 16 days]
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Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)
[Time Frame: Up to 16 days]
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Cumulative amount of TRA excreted in feces (Aefeces)
[Time Frame: Up to 16 days]
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Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
[Time Frame: Up to 16 days]
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Terminal elimination rate constant (kel)
[Time Frame: Up to 16 days]
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Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Clast/kel [AUC(0-inf)]
[Time Frame: Up to 16 days]
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Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces
[Time Frame: Up to 16 days]
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Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)
[Time Frame: Up to 16 days]
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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)]
[Time Frame: Up to 16 days]
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Fraction of the dose administered excreted in urine and feces (fetotal)
[Time Frame: Up to 16 days]
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Fraction of the dose administered excreted in feces (fefeces)
[Time Frame: Up to 16 days]
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Terminal elimination half life, calculated as 0.693/kel (t1/2)
[Time Frame: Up to 16 days]
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Time to attain maximum observed plasma concentration (tmax)
[Time Frame: Up to 16 days]
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Maximum observed plasma concentration (Cmax)
[Time Frame: Up to 16 days]
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Secondary Outcome(s)
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QT-interval measured by ECG
[Time Frame: Up to 16 days]
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QRS-duration measured by ECG
[Time Frame: Up to 16 days]
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QTc-interval (Fridericia's) measured by ECG
[Time Frame: Up to 16 days]
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Heart rate measured by ECG
[Time Frame: Up to 16 days]
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Number of adverse events (AE)
[Time Frame: Up to 16 days]
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Number of serious adverse events (SAE)
[Time Frame: Up to 16 days]
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PR-interval measured by ECG
[Time Frame: Up to 16 days]
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Number of laboratory test result abnormalities
[Time Frame: Up to 16 days]
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Secondary ID(s)
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IM014-016
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2017-002706-12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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