---
title: A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
nct_id: NCT06433505
overall_status: COMPLETED
phase: PHASE1
sponsor: Celgene
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06433505.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06433505"
ct_last_update_post_date: 2025-03-26
last_seen_at: "2026-05-12T06:21:45.581Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT06433505](https://clinicaltrials.gov/study/NCT06433505)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Celgene
- **Conditions:** Healthy Volunteers
- **Start Date:** 2024-05-30
- **Completion Date:** 2025-02-28
- **CT.gov Last Update:** 2025-03-26

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **Part A** (EXPERIMENTAL)
- **Part B - Arm 1** (EXPERIMENTAL)
- **Part B - Arm 2** (EXPERIMENTAL)

## Interventions

- **BMS-986365** (DRUG) — Specified dose on specified days
- **[14C] BMS-986365** (DRUG) — Specified dose on specified days.
- **[14C] BMS-986409 + BMS-986410** (DRUG) — Specified dose on specified days
- **[14C] BMS-986410 + BMS-986409** (DRUG) — Specified dose on specified days

## Primary Outcomes

- **Maximum observed concentration (Cmax)** _(time frame: Up to Day 60)_ — Part A and B
- **Time of maximum observed concentration (Tmax)** _(time frame: Up to Day 60)_ — Part A and B
- **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)_ — Part A and B
- **Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))** _(time frame: Up to Day 60)_ — Part A and B
- **Apparent terminal plasma half-life (T-HALF)** _(time frame: Up to Day 60)_ — Part A and B
- **Total body clearance (CLT)** _(time frame: Up to Day 15)_ — Part A
- **Apparent total body clearance (CLT/F)** _(time frame: Up to Day 60)_ — Part A and B
- **Mean residence time (MRT)** _(time frame: Up to Day 15)_ — Part A
- **Apparent volume of distribution (Vz)** _(time frame: Up to Day 15)_ — Part A
- **Apparent volume of distribution (Vz/F)** _(time frame: Up to Day 60)_ — Part A and B
- **Absolute bioavailability (F)** _(time frame: Up to Day 15)_ — Part A

## Secondary Outcomes

- **Number of participants with Adverse Events** _(time frame: Up to Day 60)_
- **Number of participants with Serious Adverse Events** _(time frame: Up to Day 60)_
- **Number of participants with AEs leading to discontinuation** _(time frame: Up to Day 60)_
- **Number of participants with Vital sign abnormalities** _(time frame: Up to Day 60)_
- **Number of participants with electrocardiogram (ECG) abnormalities** _(time frame: Up to Day 60)_
- **Number of participants with physical examination abnormalities** _(time frame: Up to Day 60)_
- **Number of participants with clinical laboratory abnormalities** _(time frame: Up to Day 60)_

## Locations (1)

- Local Institution - 0001, Madison, Wisconsin, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.local institution - 0001|madison|wisconsin|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06433505.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06433505*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*