Thorough QT Study of Nelfinavir

Phase 4

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT00312182
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-05
• Study First Submitted QC: 2006-04-05
• Study First Posted: 2006-04-07
• Study Completion: 2006-06
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-09
• Last Update Posted: 2009-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
ECG evaluation

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore