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Completed

NCT Number: NCT03245515

A Study of BMS-986195 in Healthy Male Subjects

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

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986195

Drug

specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 16 days

  2. Time to attain maximum observed plasma concentration (tmax)

    Time frame: Up to 16 days

  3. 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

  4. Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]

    Time frame: Up to 16 days

  5. Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)

    Time frame: Up to 16 days

  6. Terminal elimination rate constant (kel)

    Time frame: Up to 16 days

  7. Terminal elimination half life, calculated as 0.693/kel (t1/2)

    Time frame: Up to 16 days

  8. Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)

    Time frame: Up to 16 days

  9. Apparent volume of distribution at terminal phase (Vz/F)

    Time frame: Up to 16 days

  10. Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)

    Time frame: Up to 16 days

  11. Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)

    Time frame: Up to 16 days

  12. Cumulative amount of TRA excreted in urine (Aeurine)

    Time frame: Up to 16 days

  13. Cumulative amount of TRA excreted in feces (Aefeces)

    Time frame: Up to 16 days

  14. Cumulative amount of TRA excreted in bile (Aebile)

    Time frame: Up to 16 days

  15. Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces

    Time frame: Up to 16 days

  16. Fraction of the dose administered excreted in urine (feurine)

    Time frame: Up to 16 days

  17. Fraction of the dose administered excreted in feces (fefeces)

    Time frame: Up to 16 days

  18. Fraction of the dose administered excreted in bile (febile)

    Time frame: Up to 16 days

  19. Fraction of the dose administered excreted in urine and feces (fetotal)

    Time frame: Up to 16 days

Secondary outcomes

  1. Number of adverse events (AE)

    Time frame: Up to 16 days

  2. Number of serious adverse events (SAE)

    Time frame: Up to 16 days

  3. Number of laboratory test result abnormalities

    Time frame: Up to 16 days

  4. Heart rate measured by ECG

    Time frame: Up to 16 days

  5. PR-interval measured by ECG

    Time frame: Up to 16 days

  6. QRS-duration measured by ECG

    Time frame: Up to 16 days

  7. QT-interval measured by ECG

    Time frame: Up to 16 days

  8. QTc-interval (Fridericia's) measured by ECG

    Time frame: Up to 16 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2017
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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