Skip to main content
OpenTrials
Completed

NCT Number: NCT01153542

Study of VX-770 on Desipramine

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

In Development for Cystic Fibrosis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance CRU, Inc.

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VX-770

Drug

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

Primary outcomes

  1. VX-770 and Desipramine pharmacokinetic parameters

    Time frame: 3 weeks

Secondary outcomes

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

    Time frame: 3 weeks

  2. Metabolites pharmacokinetic parameters in plasma

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 30, 2010
Registry last updated
Dec 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.