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

Pfizer1 site in 1 country9 target enrollmentJuly 2012

ConditionsTTR Cardiomyopathy

InterventionsTafamidis

DrugsTafamidis

Overview

Phase: Phase 1
Intervention: Tafamidis
Conditions: TTR Cardiomyopathy
Sponsor: Pfizer
Enrollment: 9
Locations: 1
Primary Endpoint: 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,
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

September 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Period 1

240 mg tafamidis arm

Intervention: Tafamidis

Period 2

480 mg arm

Intervention: Tafamidis

Period 3

TBD dose

Intervention: Tafamidis

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

Secondary Outcomes

Cmax - Maximum Observed Plasma Concentration (Cmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
tmax - Time to Reach Maximum Observed Plasma Concentration (Tmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
AUC0-24 - AreArea under the Concentration-Time Curve (AUC)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
AUClast - Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
AUCinf - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)](0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
t½ - Plasma Decay Half-Life (t1/2)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
Transthyretin blood concentration in mg/dL(Days 0,1,2,3,4,5,6)
Transthyretin stabilization (%)(Days 0,1,2,3,4,5,6)