Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

Pfizer9 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

TTR Cardiomyopathy

Interventions

TafamidisDRUG

240 mg, solution, single dose

TafamidisDRUG

480 mg, solution, single dose

TafamidisDRUG

TBD dose will be a single dose if \< 720 mg or a loading dose followed by additional dose if \> 720 mg.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Singapore, Singapore, Singapore

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of orally administered tafamidis in healthy volunteers at escalating doses >120 mg. Safety assessments will include spontaneous reporting of adverse events, concomitant medications, physical examination,

Time frame: Day 0 and Day 6

vital signs, ECGs, and clinical laboratory tests.

Time frame: Day 0 and Day 6