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Thorough QT Study of Nelfinavir

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00312182
First Posted: April 7, 2006
Last Update Posted: April 10, 2009
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:
Pfizer
  Purpose
To assess if nelfinavir has any clinically meaninful effect on cardiac function, namely ECG evaluation

Condition Intervention Phase
Healthy Volunteers Drug: Nelfinavir Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation Of The Effect Of Nelfinavir On QT Intervals At Steady-State After Twice-Daily Administration Of Nelfinavir Tablets To Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • ECG evaluation

Secondary Outcome Measures:
  • Pharmacokinetics

Enrollment: 68
Study Start Date: March 2006
Study Completion Date: June 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of approximately 18 to 30 kg/m2.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  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): NCT00312182


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48105
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Singapore
Pfizer Investigational Site
Singapore, Singapore, 169608
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00312182     History of Changes
Other Study ID Numbers: A4301023
First Submitted: April 5, 2006
First Posted: April 7, 2006
Last Update Posted: April 10, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Nelfinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents