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
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, see Learn About Clinical Studies.

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 July 20, 2014