## Protocol Section
### Identification Module
**NCT ID:** NCT06417229

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

**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

#### Organization Study ID Info
**ID:** CA228-1011
#### Organization
**Class:** INDUSTRY
**Full Name:** Celgene
### Status Module
#### Completion Date
**Date:** 2024-12-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11-18

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-16

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Celgene

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Healthy Participants

**Keywords:**

- BMS-986365

- Pharmacokinetics

- Relative Bioavailability

- Healthy Male Volunteers

- CC-94676

- Food Effect

- Proton Pump Inhibitor

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 82

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BMS-986365

**Label:** Part 1: Cohort 1 BMS-986365 Dose 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: BMS-986365

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

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: BMS-986365

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

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Drug: BMS-986365

**Label:** Part 1: Cohort 3 BMS-986365 Dose 4

**Type:** EXPERIMENTAL

#### Arm Group 5

**Intervention Names:**

- Drug: BMS-986365

**Label:** Part 1: Cohort 6 BMS-986365 Dose 5

**Type:** EXPERIMENTAL

#### Arm Group 6

**Intervention Names:**

- Drug: BMS-986365

**Label:** Part 1: Cohort 7 BMS-986365 Dose 6

**Type:** EXPERIMENTAL

#### Arm Group 7

**Intervention Names:**

- Drug: BMS-986365

**Label:** Part 1: Cohort 8 BMS-986365 Dose 7

**Type:** EXPERIMENTAL

#### Arm Group 8

**Intervention Names:**

- Drug: BMS-986365

**Label:** Part 2: Cohort 4 BMS-986365 Dose 8 Fasted

**Type:** EXPERIMENTAL

#### Arm Group 9

**Intervention Names:**

- Drug: BMS-986365

**Label:** Part 2: Cohort 4 BMS-986365 Dose 9 Fed

**Type:** EXPERIMENTAL

#### Arm Group 10

**Intervention Names:**

- Drug: Rabeprazole

**Label:** Part 2: Cohort 5 BMS-986365 Dose 10 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Part 1: Cohort 1 BMS-986365 Dose 1

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

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

- Part 1: Cohort 3 BMS-986365 Dose 4

- Part 1: Cohort 6 BMS-986365 Dose 5

- Part 1: Cohort 7 BMS-986365 Dose 6

- Part 1: Cohort 8 BMS-986365 Dose 7

- Part 2: Cohort 4 BMS-986365 Dose 8 Fasted

- Part 2: Cohort 4 BMS-986365 Dose 9 Fed

**Description:** Specified dose on specified days

**Name:** BMS-986365

**Other Names:**

- CC-94676

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Part 2: Cohort 5 BMS-986365 Dose 10 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365

**Description:** Specified dose on specified days

**Name:** Rabeprazole

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Maximum observed plasma concentration (Cmax)

**Time Frame:** Up to Day 75

**Measure:** Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]

**Time Frame:** Up to Day 75

**Measure:** Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

**Time Frame:** Up to Day 75

#### Secondary Outcomes

**Measure:** To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation

**Time Frame:** Up to Day 75

**Measure:** Incidence of adverse events (AE)

**Time Frame:** Up to Day 75

**Measure:** Incidence of serious adverse events (SAE)

**Time Frame:** Up to Day 75

**Measure:** Number of participants with physical examination abnormalities

**Time Frame:** Up to Day 75

**Measure:** Number of participants with vital sign abnormalities

**Time Frame:** Up to Day 75

**Measure:** Number of participants with clinical laboratory abnormalities

**Time Frame:** Up to Day 75

**Measure:** Number of participants with electrocardiogram (ECG) abnormalities

**Time Frame:** Up to Day 75

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Clinical.Trials@bms.com

**Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com

**Phone:** 855-907-3286

**Role:** CONTACT

**Contact 2:**

**Name:** First line of the email MUST contain NCT # and Site #.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Lenexa

**Contacts:**

***Contact 1:***

- **Name:** Site 0001

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0001

**State:** Kansas

**Zip:** 66219

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** BMS Clinical Trial Information

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

**Label:** BMS Clinical Trial Patient Recruiting

**URL:** https://www.bmsstudyconnect.com/s/US/English/USenHome

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000897

- Term: Anti-Ulcer Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000054328

- Term: Proton Pump Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M30382

- Name: Rabeprazole

- Relevance: HIGH

- As Found: Total dose

- ID: M27630

- Name: Proton Pump Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4188

- Name: Antacids

- Relevance: LOW

- As Found: Unknown

- ID: M4219

- Name: Anti-Ulcer Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000064750

- Term: Rabeprazole

### Misc Info Module

- Version Holder: 2024-05-31
