Mediators of Inflammation Clinical Trial
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
| Verified date | March 2022 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a study of experimental medication BMS-986235 in healthy subjects.
| Status | Completed |
| Enrollment | 122 |
| Est. completion date | July 2, 2021 |
| Est. primary completion date | July 2, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Anaheim Clinical Trials | Anaheim | California |
| United States | PRA Health Sciences | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of serious adverse events (SAE) | Approximately 30 days | ||
| Primary | Number of deaths | Approximately 30 days | ||
| Primary | Number of adverse events (AE) leading to study discontinuation | Approximately 30 days | ||
| Primary | Number of patients with clinically significant changes in ECG parameters, as defined by the investigator | Approximately 30 days | ||
| Primary | Number of patients with potentially clinically significant changes in vital signs | Approximately 30 days |