Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

Phase 1

Completed

• Conditions: TTR Cardiomyopathy
• Interventions: Drug: Tafamidis

• Registration Number: NCT01655511
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-08-02
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 3	Tafamidis	TBD dose
Period 1	Tafamidis	240 mg tafamidis arm
Period 2	Tafamidis	480 mg arm

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cmax - Maximum Observed Plasma Concentration (Cmax)	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
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
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
Transthyretin blood concentration in mg/dL	Days 0,1,2,3,4,5,6
Transthyretin stabilization (%)	Days 0,1,2,3,4,5,6

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore