Study of VX-770 and Rifampin in Healthy Male Subjects | NCT01018368

Studies
Study of VX-770 and Rifampin in Healthy Male Subjects

NCT01018368

Sponsor

Vertex Pharmaceuticals Incorporated

Status

Completed

Last Update Posted

May 10, 2010Estimated

Enrollment

24Estimated

Phase

Phase 1

Conditions

Cystic Fibrosis

Interventions

VX-770
Rifampin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Nov 19, 2009

First Submission Date that Met QC Criteria

Nov 19, 2009

First Posted Date

Nov 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2010

Last Update Posted Date

May 10, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.

Detailed Description

This is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to investigate the safety, tolerability and pharmacokinetics of VX 770 when administered alone or with rifampin.

All enrolled subjects will receive the same treatments and undergo the same procedures. In Period 1, subjects will receive a single dose of VX 770 on Day 1. In Period 2, subjects will receive a daily dose of rifampin on Days 1 through 10 and a single dose of VX 770 on Day 6.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VX-770	Experimental		Drug: VX-770
Rifampin	Experimental		Drug: Rifampin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VX-770	Drug	In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6.	VX-770

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VX 770 pharmacokinetic (PK) parameters		17 days

Secondary Outcomes

Measure	Description	Time Frame
VX 770 metabolite PK parameters in plasma		17 days
Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin		17 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must be male and between 18 and 55 years of age
Subject must have a body mass index (BMI) from 18 to 30 kg/m2

Exclusion Criteria:

History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject
Subjects who have active tuberculosis, human immunodeficiency virus, hepatitis C, or active hepatitis B

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
H. Frank Farmer, MD	Covance CRU, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Daytona Beach	Florida		United States

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C545203	ivacaftor
D012293	Rifampin

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided