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The purpose of this clinical trial is to compare the blood tafamidis concentration of healthy adult participants after taking two different forms of tafamidis by under fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 tablet followed by Test 2 tablet followed by Reference capsule | Experimental | On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug |
|
| Test 2 tablet followed by Reference capsule followed by Test 1 tablet | Experimental | On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug |
|
| Reference capsule followed by Test 1 tablet followed by Test 2 tablet | Experimental | On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug |
|
| Test 1 tablet followed by Reference capsule followed by Test 2 tablet | Experimental | On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug |
|
| Test 2 tablet followed by Test 1 tablet followed by Reference capsule |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafamidis | Drug | (Reference) 61 milligram (mg)free acid capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tafamidis | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose | |
| Maximum Observed Plasma Concentration (Cmax)of tafamidis. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to 72 hours(AUC72) | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours | |
| Time to reach Cmax (Tmax) | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours |
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Inclusion Criteria:
Healthy female participants of nonchildbearing potential and/or male participants who are overtly healthy as determined by medical evaluation BMI of 16-32 kg/m2; and a total body weight >45 kg (99 lb).
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAB or HCVAb. Hepatitis B vaccination is allowed. Hypersensitivity to any component of the formulations. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P-One Clinic | Hachioji-shi | Tokyo | 1920071 | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| C547076 | tafamidis |
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| Experimental |
On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug |
|
| Reference capsule followed by Test 2 tablet followed by Test 1 tablet | Experimental | On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug |
|
| Tafamidis | Drug | (Test 1) 61mg orally disintegrating tablet (ODT) with water |
|
| Tafamidis | Drug | (Test 2) 61mg ODT without water |
|
| Area under the plasma concentration-time curve from time zero to infinity (AUCinf) if data permit | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours |
| Terminal phase rate constant (kel) if data permit | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours |
| terminal phase half-life (t½) if data permit | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours |
| Number of participants with treatment emergent adverse events(TEAE) | Day 1 of dosing up to approximately 5 weeks after last dose (up to maximum of approximately 5 weeks) |