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Thorough QT Study of Nelfinavir

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ClinicalTrials.gov Identifier: NCT00312182
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : April 10, 2009
Information provided by:

Brief Summary:
To assess if nelfinavir has any clinically meaninful effect on cardiac function, namely ECG evaluation

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Nelfinavir Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
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
Study Start Date : March 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. ECG evaluation

Secondary Outcome Measures :
  1. Pharmacokinetics

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

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.

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

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
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Pfizer Investigational Site
Singapore, Singapore, 169608
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

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

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