NCT01153542

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 9, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

June 28, 2010

Last Update Submit

December 8, 2010

Conditions

In Development for Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • VX-770 and Desipramine pharmacokinetic parameters

    3 weeks

Secondary Outcomes (2)

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

    3 weeks

  • Metabolites pharmacokinetic parameters in plasma

    3 weeks

Study Arms (2)

VX-770

EXPERIMENTAL
Drug: VX-770

desipramine

EXPERIMENTAL
Drug: VX-770

Interventions

VX-770DRUG

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

desipramine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance CRU, Inc.

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

ivacaftor

Study Officials

  • H. Frank Farmer, MD

    Covance CRU, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 28, 2010

First Posted

June 30, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 9, 2010

Record last verified: 2010-12

Locations

US(1)