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The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: 960 mg tafamidis (Vyndaqel) | Experimental |
| |
| Period 2: 400 mg moxifloxacin | Experimental | 400 mg moxifloxacin |
|
| Period 3: Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Period 1 | Drug | A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval. |
|
| Measure | Description | Time Frame |
|---|---|---|
| QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time | SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours. | Scrn, -1, -0.5, 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs | |
| Tmax | 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs | |
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Inclusion Criteria:
Exclusion Criteria:
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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 | New Haven | Connecticut | 06511 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25546001 | Derived | Klamerus KJ, Watsky E, Moller R, Wang R, Riley S. The effect of tafamidis on the QTc interval in healthy subjects. Br J Clin Pharmacol. 2015 Jun;79(6):918-25. doi: 10.1111/bcp.12561. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C547076 | tafamidis |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
| Period 2 | Drug | A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval. |
|
|
| Period 3 | Drug | A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval. |
|
| Cmax |
| 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs |
| AUC0-24 | 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs |
| Brussels |
| B-1070 |
| Belgium |
| Pfizer Investigational Site | Singapore | Singapore | 188770 | Singapore |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |