A Study of Experimental Medication BMS-986235 in Healthy Subjects
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
1 other identifier
interventional
122
1 country
2
Brief Summary
This is a study of experimental medication BMS-986235 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2017
Typical duration for phase_1
2 active sites
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
First Submitted
Initial submission to the registry
November 6, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedStudy Start
First participant enrolled
November 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2021
CompletedMarch 31, 2022
March 1, 2022
3.6 years
November 6, 2017
March 16, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
Single ascending dose (SAD): BMS-986235 or Placebo
EXPERIMENTALBMS-986235 or Placebo oral dose
Multiple ascending dose (MAD): BMS-986235 or Placebo
EXPERIMENTALBMS-986235 or Placebo oral dose
Interventions
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Anaheim Clinical Trials
Anaheim, California, 92801, United States
PRA Health Sciences
Salt Lake City, Utah, 84107, United States
Related Publications (1)
Singh J, Jackson KL, Fang H, Gumanti A, Claridge B, Tang FS, Kiriazis H, Salimova E, Parker AM, Nowell C, Woodman OL, Greening DW, Ritchie RH, Head GA, Qin CX. Novel formylpeptide receptor 1/2 agonist limits hypertension-induced cardiovascular damage. Cardiovasc Res. 2024 Sep 21;120(11):1336-1350. doi: 10.1093/cvr/cvae103.
PMID: 38879891DERIVED
Related Links
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2017
First Posted
November 7, 2017
Study Start
November 15, 2017
Primary Completion
July 2, 2021
Study Completion
July 2, 2021
Last Updated
March 31, 2022
Record last verified: 2022-03