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CompletedNCT02208882Updated Jul 7, 2015

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

A Phase 1 interventional study of BMS-986120 and Placebo in Healthy Adult Volunteers, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-07.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Adult Volunteers
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Inclusion criteria

Inclusion Criteria:

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

Exclusion criteria

Exclusion Criteria:

  1. 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

  2. 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
  3. Hemoglobin or hematocrit or platelet count \<lower limit of normal (LLN)
  4. Bleeding time exceeding 8 minutes at pre-dose on Day -1
  5. 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
  6. Any significant acute or chronic medical illness
  7. Current or recent (within 3 months of study drug administration) gastrointestinal disease
  8. Any major surgery within 12 weeks of study drug administration
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Panel 1: BMS-986120 or Placebo

    BMS-986120 or Placebo multiple dose by mouth as specified

    Drug: BMS-986120 · Drug: Placebo

  • Experimental
    Panel 2: BMS-986120 or Placebo

    BMS-986120 or Placebo multiple dose by mouth as specified

    Drug: BMS-986120 · Drug: Placebo

  • Experimental
    Panel 3: BMS-986120 or Placebo + Midazolam

    BMS-986120 or Placebo (multiple dose) + Midazolam (single dose) by mouth as specified

    Drug: BMS-986120 · Drug: Placebo · Drug: Midazolam

  • Experimental
    Panel 4: BMS-986120 or Placebo

    BMS-986120 or Placebo multiple dose by mouth as specified

    Drug: BMS-986120 · Drug: Placebo

Interventions

  • DrugBMS-986120
  • DrugPlacebo
  • DrugMidazolam
06

What researchers measure

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)

07

Study locations

1 site
  • Ppd Development, Lp
    Austin, Texas 78744, United States
08

References and documents

Publications

  • Merali S, Wang Z, Frost C, Callejo M, Hedrick M, Hui L, Meadows Shropshire S, Xu K, Bouvier M, DeSouza MM, Yang J. New oral protease-activated receptor 4 antagonist BMS-986120: tolerability, pharmacokinetics, pharmacodynamics, and gene variant effects in humans. Platelets. 2022 Oct 3;33(7):969-978. doi: 10.1080/09537104.2022.2088719. Epub 2022 Jun 26. PubMed 35758258 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02208882
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Aug 5, 2014
Start date
Aug 2014
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Jul 7, 2015

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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