Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01655511

Enrollment

Registered

2012-08-02

Start date

2012-07-31

Completion date

2012-09-30

Last updated

2012-09-27

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

Conditions

TTR Cardiomyopathy

Keywords

Pharmacokinetic, pharmacodynamic

Brief summary

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

Interventions

DRUGTafamidis

240 mg, solution, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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,	Day 0 and Day 6
vital signs, ECGs, and clinical laboratory tests.	Day 0 and Day 6

Secondary

Measure	Time frame
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
Cmax - Maximum Observed Plasma Concentration (Cmax)	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
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
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026