Healthy Participants Clinical Trial
Official title:
A Phase 1, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants
The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.
| Status | Not yet recruiting |
| Enrollment | 82 |
| Est. completion date | December 10, 2024 |
| Est. primary completion date | November 18, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 60 Years |
| Eligibility | Inclusion Criteria: - Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator. - Body mass index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. Exclusion Criteria: - Any significant acute or chronic illness. - Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval. - History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions or related compounds. - Other protocol-defined inclusion/exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution - 0001 | Lenexa | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to Day 75 | ||
| Primary | Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] | Up to Day 75 | ||
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Up to Day 75 | ||
| Secondary | To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation | Up to Day 75 | ||
| Secondary | Incidence of adverse events (AE) | Up to Day 75 | ||
| Secondary | Incidence of serious adverse events (SAE) | Up to Day 75 | ||
| Secondary | Number of participants with physical examination abnormalities | Up to Day 75 | ||
| Secondary | Number of participants with vital sign abnormalities | Up to Day 75 | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to Day 75 | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 75 |
| 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 |
NCT01681186 -
A Study of LY2940680 in Healthy Participants
|
Phase 1 |