NCT02208882

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

August 4, 2014

Last Update Submit

July 3, 2015

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (2)

  • 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

    Up to 168 days

  • 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

    Up to 168 days

Secondary Outcomes (14)

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

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

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

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

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

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

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

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

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

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

  • +9 more secondary outcomes

Study Arms (4)

Panel 1: BMS-986120 or Placebo

EXPERIMENTAL

BMS-986120 or Placebo multiple dose by mouth as specified

Drug: BMS-986120Drug: Placebo

Panel 2: BMS-986120 or Placebo

EXPERIMENTAL

BMS-986120 or Placebo multiple dose by mouth as specified

Drug: BMS-986120Drug: Placebo

Panel 3: BMS-986120 or Placebo + Midazolam

EXPERIMENTAL

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

Drug: BMS-986120Drug: PlaceboDrug: Midazolam

Panel 4: BMS-986120 or Placebo

EXPERIMENTAL

BMS-986120 or Placebo multiple dose by mouth as specified

Drug: BMS-986120Drug: Placebo

Interventions

BMS-986120DRUG
Panel 1: BMS-986120 or PlaceboPanel 2: BMS-986120 or PlaceboPanel 3: BMS-986120 or Placebo + MidazolamPanel 4: BMS-986120 or Placebo
PlaceboDRUG
Panel 1: BMS-986120 or PlaceboPanel 2: BMS-986120 or PlaceboPanel 3: BMS-986120 or Placebo + MidazolamPanel 4: BMS-986120 or Placebo
MidazolamDRUG
Panel 3: BMS-986120 or Placebo + Midazolam

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ppd Development, Lp

Austin, Texas, 78744, United States

Location

Related Publications (1)

  • 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.

    PMID: 35758258DERIVED

Related Links

MeSH Terms

Interventions

BMS-986120Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 5, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

US(1)