Thorough QT Study of Nelfinavir

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00312182
First received: April 5, 2006
Last updated: April 9, 2009
Last verified: April 2009
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00312182     History of Changes
Other Study ID Numbers: A4301023
Study First Received: April 5, 2006
Last Updated: April 9, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 20, 2014