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Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

NCT01655511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2012-09-27

No results posted yet for this study

Summary

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

Conditions

  • TTR Cardiomyopathy

Interventions

DRUG

Tafamidis

240 mg, solution, single dose

DRUG

Tafamidis

480 mg, solution, single dose

DRUG

Tafamidis

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Singapore

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01655511 on ClinicalTrials.gov