Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers - Full Text View

Purpose

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

Condition	Intervention	Phase
TTR Cardiomyopathy	Drug: Tafamidis	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
Transthyretin blood concentration in mg/dL [ Time Frame: Days 0,1,2,3,4,5,6 ]
Transthyretin stabilization (%) [ Time Frame: Days 0,1,2,3,4,5,6 ]


Enrollment:	9
Study Start Date:	July 2012
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655511

Locations


Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01655511 History of Changes
Other Study ID Numbers:	B3461040
Study First Received:	July 12, 2012
Last Updated:	September 26, 2012

Keywords provided by Pfizer:


Pharmacokinetic pharmacodynamic

Additional relevant MeSH terms:


Cardiomyopathies Heart Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 27, 2017