Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06086886
Other study ID # IM055-1001
Secondary ID U1111-1270-3670
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 16, 2023
Est. completion date December 12, 2024

Study information

Verified date March 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of BMS-986454 in healthy adult participants.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date December 12, 2024
Est. primary completion date December 12, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examinations, 12-lead ECGs, and clinical laboratory tests obtained during the screening period. - Participant is willing and able to adhere to the study visit schedule and other protocol requirements. - A negative test for COVID-19, which will be performed in the manner mandated by the clinical site where this study is being conducted, at screening and admission. Exclusion Criteria: - Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted. - Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer). - Inability to be venipunctured or tolerate venous access. Note: Other protocol-defined inclusion/exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986454
Specified dose on specified days
Other:
Placebo
Specified dose on specified days

Locations

Country Name City State
United Kingdom Local Institution - 0002 London Greater London
United Kingdom Quotient Sciences Nottingham Nottingham

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events (AEs) Up to approximately 4 months
Primary Number of participants with severe adverse events (SAEs) Up to approximately 4 months
Primary Number of participants with physical examination abnormalities Up to approximately 4 months
Primary Number of participants with vital sign abnormalities Up to approximately 4 months
Primary Number of participants with electrocardiogram (ECG) abnormalities Up to approximately 4 months
Primary Number of participants with clinical laboratory abnormalities Up to approximately 4 months
Secondary Maximum observed serum concentration (Cmax) Up to approximately 3 months
Secondary Time of maximum observed serum concentration (Tmax) Up to approximately 3 months
Secondary Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)] Up to approximately 3 months
Secondary Incidence of anti-drug antibody (ADA) formation Up to approximately 3 months
See also
  Status Clinical Trial Phase
Completed NCT05445440 - A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine Phase 1
Completed NCT03712540 - An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants Phase 1
Completed NCT03649165 - A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants Phase 1
Completed NCT05956002 - A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants Phase 1
Completed NCT05539976 - A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
Withdrawn NCT04558216 - Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants Phase 1
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT06097390 - A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III Phase 1
Completed NCT05546151 - A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent Phase 1
Completed NCT05056246 - Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants Phase 1
Completed NCT04390776 - Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules. Phase 1
Completed NCT05074459 - A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines Phase 1
Enrolling by invitation NCT06089109 - Creating VIP Corps to Reduce Maternal Deaths N/A
Completed NCT05996250 - Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects N/A
Completed NCT03278080 - Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1 N/A
Completed NCT05064800 - PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants Phase 1
Completed NCT04471298 - A Study of Qishenyiqi Dripping Pills in Healthy Participants Phase 1
Completed NCT04914936 - A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196 Phase 1
Completed NCT02563262 - Human Neutral Body Posture in Weightlessness N/A
Completed NCT02882386 - Amino Acid Kinetics in Blood After Consuming Different Milk Protein Supplements N/A

External Links