A Study of Experimental Medication BMS-986235 in Healthy Subjects

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03335553
• Collaborator: (none)
• Enrollment: 122
• Locations: 2
• Arms: 2
• Actual Duration (Months): 43.5
• Patients Per Site: 61
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mediators of Inflammation	Drug: BMS-986235; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986235 in Healthy Subjects
• Actual Study Start Date: Nov 15, 2017
• Actual Primary Completion Date: Jul 2, 2021
• Actual Study Completion Date: Jul 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single ascending dose (SAD): BMS-986235 or Placebo BMS-986235 or Placebo oral dose	Drug: BMS-986235; Specified dose on specified days; Other: Placebo; Specified dose on specified days
Experimental: Multiple ascending dose (MAD): BMS-986235 or Placebo BMS-986235 or Placebo oral dose	Drug: BMS-986235; Specified dose on specified days; Other: Placebo; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Number of serious adverse events (SAE) [Approximately 30 days]

2. Number of deaths [Approximately 30 days]

3. Number of adverse events (AE) leading to study discontinuation [Approximately 30 days]

4. Number of patients with clinically significant changes in ECG parameters, as defined by the investigator [Approximately 30 days]

5. Number of patients with potentially clinically significant changes in vital signs [Approximately 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anaheim Clinical Trials	Anaheim	California	United States	92801
2	PRA Health Sciences	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03335553
• Other Study ID Numbers: CV018-001
• First Posted: Nov 7, 2017
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Inflammation

Study Results

No Results Posted as of Mar 31, 2022