## Protocol Section
### Identification Module
**NCT ID:** NCT02902679

**Brief Title:** A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment

**Official Title:** An Open-label Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment

#### Organization Study ID Info
**ID:** CV010-012
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2017-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-07-27

**Type:** ACTUAL

**Last Update Submit Date:** 2017-07-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-06

**Type:** ACTUAL

#### Start Date
**Date:** 2016-11

**Type:** ACTUAL

**Status Verified Date:** 2017-07

#### Study First Post Date
**Date:** 2016-09-16
**Type:** ESTIMATED
**Study First Submit Date:** 2016-08-24
**Study First Submit QC Date:** 2016-09-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants before and after a hemodialysis session to evaluate safety, tolerability, and pharmacokinetics in this patient population.

### Conditions Module

**Conditions:**

- Thrombosis

- Factor XI

- Renal Impairment

- ESRD (End-Stage Renal Disease)

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 6

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session

**Intervention Names:**

- Drug: BMS-986177

**Label:** End Stage Renal Disease Subjects

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- End Stage Renal Disease Subjects

**Name:** BMS-986177

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** To assess the Number of subjects with Adverse events (AEs).

**Time Frame:** Day -1 - day 3

**Measure:** To assess the Change from baseline in Physical examination parameters.

**Time Frame:** Day -1 - day 3

**Measure:** To assess the change from baseline in Electrocardiogram (ECG) assessment.

**Time Frame:** Day -1 - day 3

**Measure:** To assess the change from baseline in clinical laboratory values.

**Time Frame:** Day -1 - day 3

**Measure:** To assess the change from baseline in vital signs assessment.

**Time Frame:** Day -1 - day 3

#### Secondary Outcomes

**Measure:** To assess the change from baseline in activated partial thromboplastin time (aPTT).

**Time Frame:** Day -1 - day 3

**Measure:** To assess the change from baseline in Factor XI clotting activity (FX1c ).

**Time Frame:** Day -1 - day 3

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Classified at screening as having ESRD requiring hemodialysis at least 3 times per week for 3 months.
* Clinical, ECG, and laboratory findings consistent with renal dysfunction
* BMI of 18.0 to 38.0 kg/m2 inclusive
* Subjects must receive unfractionated heparin during dialysis treatments and are able to withstand a decrease in their established heparin dose (75% of current dose)
* Women Not of child bearing potential (WNOCBP). Sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control

Exclusion Criteria:

* History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
* Evidence or history of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising
* Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery that could interfere with absorption of study drug
* Any condition requiring anticoagulation such as, but not limited to, atrial fibrillation, mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism (other than heparin required during hemodialysis)
* Need for aspirin or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
* Other protocol defined exclusion criteria could apply

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Orlando

**Country:** United States

**Facility:** Orlando Clinical Research Center

**State:** Florida

**Zip:** 32809

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### References Module

#### See Also Links

**Label:** BMS Clinical Trial Education Resource

**URL:** http://www.bms.com/studyconnect/pages/home.aspx

**Label:** FDA Safety Alerts and Recalls

**URL:** http://www.fda.gov/Safety/Recalls/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000016769

- Term: Embolism and Thrombosis

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: ESRD (end stage renal disease)

- ID: M16686

- Name: Thrombosis

- Relevance: HIGH

- As Found: Thrombosis

- ID: M26718

- Name: Renal Insufficiency

- Relevance: HIGH

- As Found: Renal Dysfunction

- ID: M7784

- Name: Embolism

- Relevance: LOW

- As Found: Unknown

- ID: M19128

- Name: Embolism and Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007676

- Term: Kidney Failure, Chronic

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000013927

- Term: Thrombosis

### Misc Info Module

- Version Holder: 2024-05-24
