B3461114- A Phase 1, Open-Label, Randomized, Three-Treatment, Three-Period, Crossover, Single Dose Study to Estimate the Relative Bioavailability of 61 mg and 70 mg Tafamidis Free Acid Tablets to Commercial 61 mg Tafamidis Free Acid Capsule Administered Under Fasted Conditions in Healthy Adult Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509241-12-00

Acronym

B3461114

Enrollment

Registered

2024-02-12

Start date

2024-02-15

Completion date

2024-05-27

Last updated

2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aransthyretin amyloid cardiomyopathy

Brief summary

AUCinf (if data permit, otherwise AUClast) and Cmax of tafamidis.

Interventions

DRUGTafamidis round 2

DRUGTafamidis round 1

DRUGTafamidis oblong

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
AUCinf (if data permit, otherwise AUClast) and Cmax of tafamidis.	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026