Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tafamidis free acid · 5 trials · 1 indication
Area under the plasma concentration time profile from time zero extrapolated to infinite time
Peak or maximum observed concentration
AUCinf is defined as area under the concentration-time curve from time 0 to infinity, and calculated by AUC(0-tlast) + (Clast\*/kel), where Clast\* is the estimated plasma concentration at the last quantifiable time point (Clast) estimated form the log-linear regression analysis Clast\* = Clast x e\^(-kel x tlast)
Cmax is defined as maximum observed concentration.
The AUCinf was determined by AUClast+ (Clast\*/kel), where Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis; kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Cmax was observed directly from data.
| Arm | Type | Description |
|---|---|---|
| Test 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 |
| Reference capsule followed by Test 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 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 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 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 |
| Test 2 tablet followed by Test 1 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 |
| 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 |
| 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 |
| Test tablet (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed) | EXPERIMENTAL | On Day 1 of each period, participants will receive a single dose of one of the tafamidis formulations under fasted or fed conditions. Each period is separated by a washout of at least 16 days between administration of study drug. |
| Reference capsule (fasted) followed by Test tablet (fasted) followed by Test tablet (fed) | EXPERIMENTAL | On Day 1 of each period, participants will receive a single dose of one of the tafamidis formulations under fasted or fed conditions. Each period is separated by a washout of at least 16 days between administration of study drug. |
| Test tablet followed by Reference 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 tablet followed by Test 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 Free acid tablet then tafamidis meglumine capsule | EXPERIMENTAL | On Day 1 of each period, participants will receive a single dose of 1 of tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug. |
| Tafamidis meglumine capsule then Tafamidis Free acid tablet | EXPERIMENTAL | On Day 1 of each period, participants will receive a single dose of 1 of tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug. |
| Name | Type | Description |
|---|---|---|
| Tafamidis 61 mg free acid tablet (Test) | DRUG | Tafamidis 61 mg free acid tablet (Test) |
| Tafamidis 61 mg free acid capsule (Reference) | DRUG | Tafamidis 61 mg free acid capsule (Reference) |
| Tafamidis 61 mg free acid tablet (Test 1) | DRUG | Tafamidis 61 mg free acid tablet (Test 1) |
| Tafamidis 70 mg free acid tablet (Test 1) | DRUG | Tafamidis 61 mg free acid tablet (Test 1) |
| Tafamidis free acid tablet (Test) | DRUG | 12.2 mg tafamidis free acid tablet (Test) |
| Tafamidis meglumine capsule (Reference) | DRUG | Commercial 20 mg tafamidis meglumine capsule (Reference) |
| Tafamidis free acid tablet (Reference) | DRUG | Proposed commercial 12.2 mg tafamidis free acid tablet (Reference) |
| Tafamidis free acid tablet | DRUG | 12.2 mg tafamidis free acid tablet |
| Tafamidis meglumine capsule | DRUG | 20 mg tafamidis meglumine soft gelatin capsule |
Inclusion Criteria: Age and Sex: 1. Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening. 2. Healthy female participants of nonchildbearing potential and/or male participants who are overtly healthy as determined by medical evaluatio...
Tafamidis free acid is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with all completed trials enrolling healthy adults to assess how different forms of the drug are absorbed into the blood. It is not approved for any disease indication.
Tafamidis free acid is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics in healthy adult volunteers.
Tafamidis free acid is in Phase 1 clinical development. All five clinical trials for this drug have been completed, with no active trials currently ongoing. The studies have enrolled a total of 91 participants, all healthy volunteers, to evaluate the drug's absorption and bioequivalence.
Tafamidis free acid has been studied in four completed Phase 1 trials: NCT04575116, NCT05498701, NCT06273839, and NCT06705569. These trials enrolled healthy adults in the United States, Canada, and Belgium to compare different forms of the drug and assess how food affects its absorption into the blood.
Tafamidis free acid is a form of the drug tafamidis. The clinical trials listed for this asset compare different forms of tafamidis, including the free acid form, to determine their bioequivalence and how they are taken up into the blood in healthy adults.