MedDataX Logo

Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants

NCT ID: NCT06417229

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-28

Study Completion Date

2025-02-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, Proton Pump Inhibitor (PPI) Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects

NCT03464058

Healthy Subjects
COMPLETED PHASE1

A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants

NCT01277718

Healthy Volunteer
COMPLETED PHASE1

A Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole and BMS-986165 on How Fast and Complete The Drug is Absorbed Into the Body of Healthy Participants

NCT03979248

Healthy
COMPLETED PHASE1

A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)

NCT04468815

Healthy Participants
COMPLETED PHASE1

PPI And Food Effect Study For PF-06463922 In Healthy Volunteers

NCT02569554

Healthy
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1: Cohort 1 BMS-986365 Dose 1

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part 1: Cohort 3 BMS-986365 Dose 4

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part 1: Cohort 6 BMS-986365 Dose 5

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part 1: Cohort 7 BMS-986365 Dose 6

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part 1: Cohort 8 BMS-986365 Dose 7

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part 1: Cohort 9 BMS-986365 Dose 8

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part 2: Cohort 4 BMS-986365 Dose 9 Fasted

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part 2: Cohort 4 BMS-986365 Dose 10 Fed

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Rabeprazole

Intervention Type DRUG

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-986365

Specified dose on specified days

Intervention Type DRUG

Rabeprazole

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CC-94676

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0001

Lenexa, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CA228-1011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Evaluate the Relative Bioavailability of Two Tablet Formulations Compared to Capsule Formulation and the Effect of Food and Proton Pump Inhibitor on ZN-A-1041 Tablet(s) in Healthy Participants
NCT07051993 COMPLETED PHASE1
Proton Pump Inhibitor (PPI, Rabeprazole) Effect On Tablet Formulation Of Palbociclib
NCT03220191 COMPLETED PHASE1
Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects
NCT04211545 COMPLETED PHASE1
A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants
NCT03290703 COMPLETED PHASE1
A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers
NCT01101646 COMPLETED PHASE1
A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
NCT01287091 COMPLETED PHASE1
A Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers
NCT00999128 COMPLETED PHASE1
Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
NCT02097329 COMPLETED PHASE1
A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants
NCT03936374 COMPLETED PHASE1
Relative Bioavailability and Drug-drug Interaction Study With MT-7117 and a Proton Pump Inhibitor
NCT03688022 COMPLETED PHASE1
A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on MK-1084 in Healthy Adult Participants (MK-1084-003)
NCT06619314 COMPLETED PHASE1
A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants
NCT06054464 COMPLETED PHASE1
Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)
NCT01918176 COMPLETED PHASE1
A Study for Multiple Tablet Forms of The Study Medicine (PF-07220060) in Healthy Adults
NCT05923411 COMPLETED PHASE1
A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers
NCT01241409 COMPLETED PHASE1
A Study to Compare Bioavailability of AZD5055 Film-coated Tablet With AZD5055 Oral Suspension and to Assess the Effect of Food and an Acid Reducing Agent on Pharmacokinetics (PK) of AZD5055 in Healthy Subjects.
NCT05630677 COMPLETED PHASE1
Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants
NCT05330858 COMPLETED PHASE1
AZD4635 Relative Bioavailability Study
NCT03710434 COMPLETED PHASE1
A Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 in Healthy Participants
NCT07329972 RECRUITING PHASE1
To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects
NCT02509923 COMPLETED PHASE1
A Study to Investigate the Effect of Increased Gastric pH on the Oral Bioavailability of the Orexin-2 Receptor Antagonist JNJ-42847922 in Healthy Participants
NCT02475161 COMPLETED PHASE1
Relative Bioavailability of NX-5948 Tablets vs Capsules and the Effect of Covariates on the PK of NX-5948 Tablets
NCT06717269 RECRUITING PHASE1
Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects
NCT02699710 COMPLETED PHASE1
Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
NCT04470778 COMPLETED PHASE1
Study Examing The Effect Of Omeprazole On Safety, Tolerability And How The Body Processes An Experimental Drug
NCT00644839 COMPLETED PHASE1