NCT05498701

A Study Comparing Two Forms of Tafamidis Without Food and the Amount of Tafamidis in the Blood With Food

A PHASE 1, OPEN-LABEL, RANDOMIZED, CROSSOVER, SINGLE DOSE STUDY TO DETERMINE THE BIOEQUIVALENCE OF 12.2 MG TAFAMIDIS FREE ACID TABLETS AND COMMERCIAL 20 MG TAFAMIDIS MEGLUMINE CAPSULES ADMINISTERED UNDER FASTED CONDITIONS AND THE EFFECT OF FOOD ON ORAL BIOAVAILABILITY OF 12.2 MG TAFAMIDIS FREE ACID TABLETS IN HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to compare a tablet and a capsule form of tafamidis without food and to assess the amount of tafamidis in blood after taking the tablet form with food. This study is seeking healthy participants over the age of 18. All participants in the study will receive either one tablet or capsule of study medicine on the first day without food, then receive one dose of the other tablet or capsule form 16 days later without food. All participants will then receive one dose of the tablet form with food 16 days later. We will evaluate the amounts in blood for 8 days after taking each dose of the study medicine. Participants will take part in this study for about 96 days. The first visit is a screening visit to ensure that participants are appropriate for the study. Up to 28 days later, eligible participants will visit the study clinic three times (and stay overnight in the clinical research center for 8 nights each time). The study team will also call participants over the phone 28 to 35 days after the last dose of medicine.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tafamidis free acid tablet (Test)	12.2 mg tafamidis free acid tablet (Test)
DRUG	Tafamidis meglumine capsule (Reference)	Commercial 20 mg tafamidis meglumine capsule (Reference)

Timeline

• Start date: 2022-09-29
• Primary completion: 2022-12-18
• Completion: 2022-12-19
• First posted: 2022-08-12
• Last updated: 2024-06-03
• Results posted: 2024-06-03

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study