NCT05482308

A Study to Compare Two Tablet Forms of Tafamidis in Healthy Participants

A PHASE 1, OPEN-LABEL, RANDOMIZED, CROSSOVER, SINGLE DOSE STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF VARIANT 12.2 MG TAFAMIDIS FREE ACID TABLETS AND PROPOSED COMMERCIAL 12.2 MG TAFAMIDIS FREE ACID TABLETS ADMINISTERED UNDER FASTED CONDITIONS IN HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to compare the amount of tafamidis in blood after taking two different tablet forms of tafamidis This study is seeking healthy participants over the age of 18. All participants in the study will receive one tablet of study medicine on the first day, then receive one dose of the other tablet form 16 days later. We will compare the amounts in blood for 8 days after taking each dose of the study medicine. Participants will take part in this study for about 80 days. The first visit is a screening visit to ensure that participants are appropriate for the study. Up to 28 days later, they will visit the study clinic twice (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)	Variant 12.2 mg tafamidis free acid tablet (Test)
DRUG	Tafamidis free acid tablet (Reference)	Proposed commercial 12.2 mg tafamidis free acid tablet (Reference)

Timeline

• Start date: 2022-08-29
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2022-08-01
• Last updated: 2024-05-23
• Results posted: 2024-05-23

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study