Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tafamidis free acid tablet (Test), Tafamidis free acid tablet
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 a small molecule drug developed by Pfizer, Inc. (PFE). It is a stabiliser that targets the TTR protein. The specific indication for this free acid form is undisclosed, and it is currently in Phase 1 clinical development.
Tafamidis free acid targets the TTR protein. It belongs to the stabiliser class, meaning it works by stabilising the TTR protein. This mechanism is being investigated in Phase 1 trials.
Tafamidis free acid is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the sponsor of the clinical trials for this drug.
Tafamidis free acid is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All five of its clinical trials have been completed.
Tafamidis free acid has been studied in five completed Phase 1 trials, including NCT06705569, NCT06273839, NCT05498701, and NCT05482308. These trials enrolled healthy adult volunteers in Belgium and Canada to compare different forms of tafamidis.