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NCT00312182 Clinical Trial

Thorough QT Study of Nelfinavir

Healthy Volunteers Clinical Trial

Official title:
Evaluation Of The Effect Of Nelfinavir On QT Intervals At Steady-State After Twice-Daily Administration Of Nelfinavir Tablets To Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00312182
Other study ID # A4301023
Secondary ID
Status Completed
Phase Phase 4
First received April 5, 2006
Last updated April 9, 2009
Start date March 2006
Est. completion date June 2006

Study information
Verified date April 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nelfinavir

Locations
Country Name City State
Belgium Pfizer Investigational Site Bruxelles
Singapore Pfizer Investigational Site Singapore
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary ECG evaluation
Secondary Pharmacokinetics
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