Thorough QT Study of Nelfinavir

Pfizer

Status and phase: Completed; Phase 4

Conditions: Healthy Volunteers

Treatments: Drug: Nelfinavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312182

A4301023

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind