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Study of VX-770 on Desipramine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01153542
First Posted: June 30, 2010
Last Update Posted: December 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vertex Pharmaceuticals Incorporated
  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
Intervention Model: Crossover Assignment
Masking: None (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:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • VX-770 and Desipramine pharmacokinetic parameters [ Time Frame: 3 weeks ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Claudia Ordonez, MD, Vertex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01153542     History of Changes
Other Study ID Numbers: VX10-770-011
First Submitted: June 28, 2010
First Posted: June 30, 2010
Last Update Posted: December 9, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Desipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs


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