A Phase 1 interventional study of Tafamidis and Tafamidis in TTR Cardiomyopathy, sponsored by Pfizer. Completed at 1 site in Singapore. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-27.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's enrollment of 9 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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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
240 mg tafamidis arm
Drug: Tafamidis
480 mg arm
Drug: Tafamidis
TBD dose
Drug: Tafamidis
240 mg, solution, single dose
480 mg, solution, single dose
TBD dose will be a single dose if \< 720 mg or a loading dose followed by additional dose if \> 720 mg.
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
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
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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