Study of VX-770 on Desipramine

December 8, 2010 updated by: Vertex Pharmaceuticals Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Covance Cru, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VX-770
Drug: VX-770
In period 1, subjects will receive a single oral dose of desipramine on Day 1.
Drug: VX-770
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.
Experimental: desipramine
Drug: VX-770
In period 1, subjects will receive a single oral dose of desipramine on Day 1.
Drug: VX-770
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 30, 2010

Study Record Updates

Last Update Posted (Estimate)

December 9, 2010

Last Update Submitted That Met QC Criteria

December 8, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX10-770-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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