Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06705569 | A Study to Compare Two Forms of Study Medicine Tafamidis in the Blood in Healthy Adults | PHASE1 | COMPLETED | 22 | — | — | Dec 20, 2024 | Apr 4, 2025 | May 28, 2025 | 1 | Belgium |
| NCT06273839 | A Study to Learn How Different Forms of Study Medicine Tafamidis Are Taken Up Into The Blood in Healthy Adults | PHASE1 | COMPLETED | 12 | — | — | Feb 27, 2024 | May 27, 2024 | Jun 26, 2024 | 1 | Belgium |
| NCT05498701 | A Study Comparing Two Forms of Tafamidis Without Food and the Amount of Tafamidis in the Blood With Food | PHASE1 | COMPLETED | 22 | — | — | Sep 29, 2022 | Dec 19, 2022 | Jun 3, 2024 | 1 | Canada |
| NCT05482308 | A Study to Compare Two Tablet Forms of Tafamidis in Healthy Participants | PHASE1 | COMPLETED | 12 | — | — | Aug 29, 2022 | Oct 28, 2022 | May 23, 2024 | 1 | Belgium |
| NCT04575116 | A Study to Determine the Bioequivalence of Two Doses of Tafamidis | PHASE1 | COMPLETED | 23 | — | — | Sep 17, 2020 | Feb 23, 2021 | Mar 8, 2021 | 1 | United States |
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...