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

April 5, 2006
April 9, 2009
March 2006
Not Provided
ECG evaluation
Same as current
Complete list of historical versions of study NCT00312182 on ClinicalTrials.gov Archive Site
Pharmacokinetics
Same as current
Not Provided
Not Provided
 
Thorough QT Study of Nelfinavir
Evaluation Of The Effect Of Nelfinavir On QT Intervals At Steady-State After Twice-Daily Administration Of Nelfinavir Tablets To Healthy Volunteers

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy Volunteers
Drug: Nelfinavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
June 2006
Not Provided

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Singapore
 
NCT00312182
A4301023
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP