Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Crossover, Ascending Dose-Tolerance Study To Assess The Safety And Pharmacokinetics Of Tafamidis Doses Greater Than 120 Mg As Oral Solution In Healthy Volunteers

This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis

Inclusion Criteria:

• Healthy, males or females, 21 to 55 years old.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Condition affecting drug absorption. Blood pressure or ECG abnormalities. Recent treatment with an investigational, prescription, or non-prescription drug