Study of VX-770 on Desipramine | NCT01153542

Studies
Study of VX-770 on Desipramine

NCT01153542

Sponsor

Vertex Pharmaceuticals Incorporated

Status

Completed

Last Update Posted

Dec 9, 2010Estimated

Enrollment

24Estimated

Phase

Phase 1

Conditions

In Development for Cystic Fibrosis

Interventions

VX-770
VX-770

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

Dec 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

Jun 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Jun 28, 2010

First Submission Date that Met QC Criteria

Jun 28, 2010

First Posted Date

Jun 30, 2010Estimated

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

Dec 8, 2010

Last Update Posted Date

Dec 9, 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

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
desipramine	Experimental		Drug: VX-770

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VX-770	Drug	In period 1, subjects will receive a single oral dose of desipramine on Day 1.	desipramine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VX-770 and Desipramine pharmacokinetic parameters		3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments		3 weeks
Metabolites pharmacokinetic parameters in plasma		3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be male or female and between 18 and 55 years of age
Subject must have a body mass index (BMI) from 18 to 30 kg/m2
Subject must be judged to be in good health

Exclusion Criteria:

History of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
Subjects who have human immunodeficiency virus, hepatitis C, or active hepatitis B
Female subjects and male subjects with female partner(s) who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug

Accepts Healthy Volunteers

Yes

Sex

All

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
Covance CRU, Inc.		Daytona Beach	Florida	32117	United States

Intervention Browse Module

MeSH Terms

ID	Term
C545203	ivacaftor

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided