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| ID | Type | Description | Link |
|---|---|---|---|
| B3461040 |
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This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | 240 mg tafamidis arm |
|
| Period 2 | Experimental | 480 mg arm |
|
| Period 3 | Experimental | TBD dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafamidis | Drug | 240 mg, solution, single dose |
| |
| Tafamidis |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | Singapore | 188770 | Singapore |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C547076 | tafamidis |
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| Drug |
480 mg, solution, single dose |
|
| Tafamidis | Drug | TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg. |
|
| 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 |