Healthy Participants Clinical Trial
Official title:
A Phase 1, Double-blinded, Randomized, Placebo-controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986454 in Healthy Participants
The purpose of this study is to assess the safety and tolerability of BMS-986454 in healthy adult participants.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Local Institution - 0002 | London | Greater London |
| United Kingdom | Quotient Sciences Nottingham | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United Kingdom,
| 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 |
| 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 |
NCT02882386 -
Amino Acid Kinetics in Blood After Consuming Different Milk Protein Supplements
|
N/A | |
| Completed |
NCT01681186 -
A Study of LY2940680 in Healthy Participants
|
Phase 1 |