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Study of VX-770 on Desipramine

Primary Purpose

In Development for Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VX-770

About this trial

This is an interventional treatment trial for In Development for Cystic Fibrosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Covance CRU, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

VX-770

desipramine

Arm Description

Outcomes

Primary Outcome Measures

VX-770 and Desipramine pharmacokinetic parameters

Secondary Outcome Measures

Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments

Metabolites pharmacokinetic parameters in plasma

Full Information

NCT ID

NCT01153542

First Posted

June 28, 2010

Last Updated

December 8, 2010

Sponsor

Vertex Pharmaceuticals Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01153542

Brief Title

Study of VX-770 on Desipramine

Official Title

An Open-Label Phase 1 Study to Examine the Effect of VX 770 on Desipramine in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to evaluate the effects of VX-770 on Desipramine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

In Development for Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VX-770

Arm Type

Experimental

Arm Title

desipramine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

VX-770

Intervention Description

In period 1, subjects will receive a single oral dose of desipramine on Day 1.

Intervention Type

Drug

Intervention Name(s)

VX-770

Intervention Description

In period 2, subjects will receive 150 mg VX-770 q12h orally from the morning of Day 1 through the evening of Day 9. Subjects will receive 50 mg Desipramine as a single dose on Day 5 of period 2.

Primary Outcome Measure Information:

Title

VX-770 and Desipramine pharmacokinetic parameters

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments

Time Frame

3 weeks

Title

Metabolites pharmacokinetic parameters in plasma

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

H. Frank Farmer, MD

Organizational Affiliation

Covance CRU, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Covance CRU, Inc.

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of VX-770 on Desipramine

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