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Completed

NCT Number: NCT02208882

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986120 in Healthy Subjects and the Effects of Co-Administration of Midazolam and BMS-986120

The purpose of this study is to assess the safety, tolerability and effect on Midazolam pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.

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Key information

Conditions

Healthy Adult Volunteers

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ppd Development, Lp

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/[Height(m)]2
  • Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive

Exclusion criteria

  • Concurrent, or use within 2-weeks of study drug administration, of marketed or investigational, non-steroidal anti-inflammatory compounds (NSAIDS), aspirin or other antiplatelet agents, oral or parenteral anticoagulants
  • Subjects at screening or prior to first dose with the following abnormal laboratory values upon repeat testing are excluded:
  • i) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >upper limit of normal (ULN)
  • ii) Total bilirubin >ULN, thyroid-stimulating hormone (TSH) >1.5 x ULN with T4 within normal limits (Subjects with mild unconjugated hyperbilirubinemia due to Gilbert's syndrome are excluded)
  • iii) CK >3 x ULN (unless exercise related and CK-MB within normal limits)
  • iv) Activated partial thromboplastin (aPTT) or Prothrombin Time (PT)/International Normalized Ratio (INR) >ULN
  • v) Blood urea nitrogen (BUN) or creatinine (Cr) >ULN
  • Hemoglobin or hematocrit or platelet count <lower limit of normal (LLN)
  • Bleeding time exceeding 8 minutes at pre-dose on Day -1
  • Subjects with micro- or macro-hematuria and/or fecal occult blood detected during screening, baseline or documented during other recent medical assessment, unless deemed not clinically significant by the Investigator and Medical Monitor
  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease
  • Any major surgery within 12 weeks of study drug administration

Treatment and study plan

BMS-986120

Drug

Placebo

Drug

midazolam

Drug

Primary outcomes

  1. Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters

    Time frame: Up to 168 days

  2. Safety and tolerability measured by percent of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters

    Time frame: Up to 168 days

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  2. Time of maximum observed plasma concentration (Tmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  3. Area under the concentration-time curve from time zero to 24h [AUC(TAU)] of BMS-986120 and BMT-141464

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  4. Concentration at the end of the dosing Interval (Ctau) of BMS-986120 and BMT-141464

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  5. Half-life (T-HALF) of BMS-986120 and BMT-141464

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  6. Apparent total body clearance (CLT/F) of BMS-986120, Midazolam, and 1'hydroxymidazolam

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  7. AUC accumulation index (AI_AUC) of BMS-986120 and BMT-141464

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  8. Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986120

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  9. Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMT-141464

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  10. Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMT-141464

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  11. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Midazolam and 1'hydroxymidazolam

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  12. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Midazolam and 1'hydroxymidazolam

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  13. Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)] of 1'hydroxymidazolam

    Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)

  14. Change from baseline in protease-activated receptor-4 - agonist peptide (PAR4-AP) induced platelet aggregation of BMS-986120

    Time frame: Part A (Days 1-3) & Part B/C (Days 1-19)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of BMS-986120 in Healthy Subjects and the Effect of BMS-986120 on the Pharmacokinetics of Midazolam in Healthy Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2014
Registry last updated
Jul 7, 2015

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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