Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
TTR Cardiomyopathy	Drug: Tafamidis	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	9 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Basic Science
Official Title:	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
Study Start Date :	July 2012
Actual Primary Completion Date :	September 2012
Actual Study Completion Date :	September 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Period 1; 240 mg tafamidis arm	Drug: Tafamidis; 240 mg, solution, single dose
Experimental: Period 2; 480 mg arm	Drug: Tafamidis; 480 mg, solution, single dose
Experimental: Period 3; TBD dose	Drug: Tafamidis; TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg.

Outcome Measures

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Primary Outcome Measures :

1. 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, [ Time Frame: Day 0 and Day 6 ]
2. vital signs, ECGs, and clinical laboratory tests. [ Time Frame: Day 0 and Day 6 ]

Secondary Outcome Measures :

1. Cmax - Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ]
2. tmax - Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ]
3. AUC0-24 - AreArea under the Concentration-Time Curve (AUC) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ]
4. AUClast - Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ]
5. AUCinf - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ]
6. t½ - Plasma Decay Half-Life (t1/2) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs ]
7. Transthyretin blood concentration in mg/dL [ Time Frame: Days 0,1,2,3,4,5,6 ]
8. Transthyretin stabilization (%) [ Time Frame: Days 0,1,2,3,4,5,6 ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Locations

Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01655511 History of Changes
Other Study ID Numbers:	B3461040
First Posted:	August 2, 2012
Last Update Posted:	September 27, 2012
Last Verified:	September 2012

Keywords provided by Pfizer:

Pharmacokinetic; pharmacodynamic

Additional relevant MeSH terms:

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases