## Protocol Section
### Identification Module
**NCT ID:** NCT06433505

**Brief Title:** A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants

**Official Title:** A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants

#### Organization Study ID Info
**ID:** CA071-1005
#### Organization
**Class:** INDUSTRY
**Full Name:** Celgene
### Status Module
#### Completion Date
**Date:** 2024-09-23

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-23

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### 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 objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.

### Conditions Module

**Conditions:**

- Healthy Volunteers

**Keywords:**

- BMS-986365

- Pharmacokinetics

- Absolute Bioavailability

- Healthy Male Volunteers

- CC-94676

- ADME

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 24

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BMS-986365

- Drug: [14C] BMS-986365

**Label:** Part A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: [14C] BMS-986409 + BMS-986410

**Label:** Part B - Arm 1

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: [14C] BMS-986410 + BMS-986409

**Label:** Part B - Arm 2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Part A

**Description:** Specified dose on specified days

**Name:** BMS-986365

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Part A

**Description:** Specified dose on specified days.

**Name:** [14C] BMS-986365

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Part B - Arm 1

**Description:** Specified dose on specified days

**Name:** [14C] BMS-986409 + BMS-986410

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Part B - Arm 2

**Description:** Specified dose on specified days

**Name:** [14C] BMS-986410 + BMS-986409

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Part A and B

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

**Time Frame:** Up to Day 60

**Description:** Part A and B

**Measure:** Time of maximum observed concentration (Tmax)

**Time Frame:** Up to Day 60

**Description:** Part A and B

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

**Time Frame:** Up to Day 60

**Description:** Part A and B

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

**Time Frame:** Up to Day 60

**Description:** Part A and B

**Measure:** Apparent terminal plasma half-life (T-HALF)

**Time Frame:** Up to Day 60

**Description:** Part A

**Measure:** Total body clearance (CLT)

**Time Frame:** Up to Day 15

**Description:** Part A and B

**Measure:** Apparent total body clearance (CLT/F)

**Time Frame:** Up to Day 60

**Description:** Part A

**Measure:** Mean residence time (MRT)

**Time Frame:** Up to Day 15

**Description:** Part A

**Measure:** Apparent volume of distribution (Vz)

**Time Frame:** Up to Day 15

**Description:** Part A and B

**Measure:** Apparent volume of distribution (Vz/F)

**Time Frame:** Up to Day 60

**Description:** Part A

**Measure:** Absolute bioavailability (F)

**Time Frame:** Up to Day 15

#### Secondary Outcomes

**Description:** Part A and B

**Measure:** Number of participants with Adverse Events

**Time Frame:** Up to Day 60

**Description:** Part A and B

**Measure:** Number of participants with Serious Adverse Events

**Time Frame:** Up to Day 60

**Description:** Part A and B

**Measure:** Number of participants with AEs leading to discontinuation

**Time Frame:** Up to Day 60

**Description:** Part A and B

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

**Time Frame:** Up to Day 60

**Description:** Part A and B

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

**Time Frame:** Up to Day 60

**Description:** Part A and B

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

**Time Frame:** Up to Day 60

**Description:** Part A and B

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

**Time Frame:** Up to Day 60

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator
* Participants will require a left ventricular ejection fraction of \> 50% at screening.
* Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height \[m\])2.

Exclusion Criteria:

* Any current or recent significant acute or chronic illness.
* Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (\> 450 ms) at screening.
* Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary.
* History of allergy to BMS-986365 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 the NCT# and Site #.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Madison

**Contacts:**

***Contact 1:***

- **Name:** Site 0001

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0001

**State:** Wisconsin

**Zip:** 53704

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### 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

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
