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Study of VX-770 on Desipramine

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01153542
First received: June 28, 2010
Last updated: December 8, 2010
Last verified: December 2010
History of Changes
  Purpose

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


Condition Intervention Phase
In Development for Cystic Fibrosis
 Drug: VX-770
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase 1 Study to Examine the Effect of VX 770 on Desipramine in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • VX-770 and Desipramine pharmacokinetic parameters [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Metabolites pharmacokinetic parameters in plasma [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VX-770 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153542

Locations
United States, Florida
Covance CRU, Inc.
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Principal Investigator: H. Frank Farmer, MD Covance CRU, Inc.
  More Information

No publications provided

Responsible Party: Claudia Ordonez, MD, Vertex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01153542     History of Changes
Other Study ID Numbers: VX10-770-011
Study First Received: June 28, 2010
Last Updated: December 8, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Desipramine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013