Thorough QT Study of Nelfinavir

Phase 4CompletedNCT00312182

Pfizer68 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

NelfinavirDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Pfizer Investigational Site

New Haven, Connecticut, United States

Pfizer Investigational Site

Ann Arbor, Michigan, United States

Pfizer Investigational Site

Brussels, Belgium

Pfizer Investigational Site

Singapore, Singapore

Outcomes

Primary Outcomes

ECG evaluation

Secondary Outcomes

Pharmacokinetics

Data from ClinicalTrials.gov

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