Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: TTR Cardiomyopathy

Treatments: Drug: Tafamidis

Study type: Interventional

Funder types: Industry

Identifiers

NCT01655511

B3461040

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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9 participants in 3 patient groups

Period 1

Experimental group

Description:

240 mg tafamidis arm

Treatment:

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Period 2

Experimental group

Description:

480 mg arm

Treatment:

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis

Period 3

Experimental group

Description:

TBD dose

Treatment:

Drug: Tafamidis

Drug: Tafamidis

Drug: Tafamidis