A Study of Experimental Medication BMS-986235 in Healthy Subjects

Phase 1

Completed

• Conditions: Mediators of Inflammation
• Interventions: Drug: BMS-986235; Other: Placebo

• Registration Number: NCT03335553
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This is a study of experimental medication BMS-986235 in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-07
• Study Start: 2017-11-15
• Primary Completion: 2021-07-02
• Study Completion: 2021-07-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
• Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive

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Exclusion Criteria

• Patients that are pregnant
• Patient with any significant acute or chronic medical illness
• Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
• Patient with any surgery within 12 weeks of study treatment administration
• Patient with any gastrointestinal surgery that could impact upon the absorption of study drug
• Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only)
• Patient who received a blood transfusion within 12 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple ascending dose (MAD): BMS-986235 or Placebo	Placebo	BMS-986235 or Placebo oral dose
Single ascending dose (SAD): BMS-986235 or Placebo	BMS-986235	BMS-986235 or Placebo oral dose
Single ascending dose (SAD): BMS-986235 or Placebo	Placebo	BMS-986235 or Placebo oral dose
Multiple ascending dose (MAD): BMS-986235 or Placebo	BMS-986235	BMS-986235 or Placebo oral dose

Primary Outcome Measures

Name	Time	Method
Number of serious adverse events (SAE)	Approximately 30 days
Number of deaths	Approximately 30 days
Number of adverse events (AE) leading to study discontinuation	Approximately 30 days
Number of patients with clinically significant changes in ECG parameters, as defined by the investigator	Approximately 30 days
Number of patients with potentially clinically significant changes in vital signs	Approximately 30 days

Trial Locations

Locations (2)

PRA Health Sciences; 🇺🇸 Salt Lake City, Utah, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States