## Protocol Section
### Identification Module
**NCT ID:** NCT01002079

**Brief Title:** Drug-Drug Interaction Study With Rifampin

**Official Title:** A Study of the Effect of Concomitant Administration of Rifampin on the Pharmacokinetics of BMS-708163 in Healthy Subjects

#### Organization Study ID Info
**ID:** CN156-028
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2010-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-01-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-01-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-10

**Type:** ACTUAL

#### Start Date
**Date:** 2010-08

**Status Verified Date:** 2010-11

#### Study First Post Date
**Date:** 2009-10-27
**Type:** ESTIMATED
**Study First Submit Date:** 2009-10-26
**Study First Submit QC Date:** 2009-10-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** PRA Health Sciences

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Responsible Party

**Old Name Title:** Study Director

**Old Organization:** Bristol-Myers Squibb

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of the study is to determine if the concomitant administration of rifampin with BMS-708163 will affect the Pharmacokinetics of BMS-708163 and to assess safety and tolerability of co-administration BMS-708163 and rifampin

### Conditions Module

**Conditions:**

- Alzheimer Disease

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BMS-708163

**Label:** BMS-708163

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Rifampin

**Label:** Rifampin

**Type:** OTHER

#### Arm Group 3

**Intervention Names:**

- Drug: BMS-708163

- Drug: Rifampin

**Label:** Rifampin + BMS-708163

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BMS-708163

- Rifampin + BMS-708163

**Description:** Capsule, Oral, 125 mg, Once daily, 1 day

**Name:** BMS-708163

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Rifampin

**Description:** Capsule, Oral, 600 mg, Once daily, 7 days

**Name:** Rifampin

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Rifampin + BMS-708163

**Description:** Capsule, Oral, 600 mg, Once daily, 6 days

**Name:** Rifampin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** BMS-708163 alone and with rifampin: BMS-708163 single dose PK parameters (Cmax, Tmax, T-HALF, AUC(0-T), AUC(INF), CLT/F and molar AUCmet/AUCparent ratios will be assessed without rifampin (Day 1) and with rifampin (Day 13)

**Time Frame:** Within 30 days after dose

#### Secondary Outcomes

**Measure:** BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs)

**Time Frame:** Within 30 days after dose

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy male and postmenopausal female subjects, 18-55 yrs old inclusive

Exclusion Criteria:

* Women of childbearing potential
* Tuberculosis

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bangalore

**Country:** India

**Facility:** Local Institution

**Zip:** 560100

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003704

- Term: Dementia

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000024801

- Term: Tauopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3885

- Name: Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23002

- Name: Tauopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000544

- Term: Alzheimer Disease

### Intervention Browse Module - Ancestors

- ID: D000000904

- Term: Antibiotics, Antitubercular

- ID: D000000995

- Term: Antitubercular Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000007917

- Term: Leprostatic Agents

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000065695

- Term: Cytochrome P-450 CYP2B6 Inducers

- ID: D000065693

- Term: Cytochrome P-450 Enzyme Inducers

- ID: D000065696

- Term: Cytochrome P-450 CYP2C8 Inducers

- ID: D000065697

- Term: Cytochrome P-450 CYP2C19 Inducers

- ID: D000065698

- Term: Cytochrome P-450 CYP2C9 Inducers

- ID: D000065701

- Term: Cytochrome P-450 CYP3A Inducers

- ID: D000091062

- Term: Gamma Secretase Inhibitors and Modulators

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M15118

- Name: Rifampin

- Relevance: HIGH

- As Found: Match

- ID: M348455

- Name: BMS 708163

- Relevance: HIGH

- As Found: Complete denture

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M4311

- Name: Antitubercular Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M2816

- Name: Gamma Secretase Inhibitors and Modulators

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000012293

- Term: Rifampin

- ID: C000554092

- Term: BMS 708163

### Misc Info Module

- Version Holder: 2024-05-24
