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Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects

Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, and Pharmacokinetics of BMS-986142 in Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02257151
Enrollment
118
Registered
2014-10-06
Start date
2014-09-30
Completion date
2015-08-31
Last updated
2015-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult

Keywords

Volunteers

Brief summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement of BMS-986142 in healthy subjects.

Detailed description

Allocation: Randomized Controlled Trial (SAD/MAD) Masking: Double-Blind (SAD/MAD)

Interventions

DRUGPlacebo

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

1. Any significant acute or chronic medical illness 2. Current or recent (within 3 months of study drug administration) gastrointestinal disease 3. Any major surgery within 4 weeks of study drug administration 4. Any gastrointestinal surgery that could impact upon the absorption of study drug 5. Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)

Design outcomes

Primary

MeasureTime frame
Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142Single Ascending Dose(SAD) within 8 days
Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after multiple doses of BMS-986142Multiple Ascending Dose (MAD) within 19 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026