| Autor: |
DuBois, Janet, Jones, Terry M., Lee, Mark S., Falqués, Meritxell, Kiyasova, Vera, Jiménez, Gemma, Otero, Raquel, Jansat, Josep‐M., Aubets, Jordi, Forconi, Rion James |
| Zdroj: |
Clinical Pharmacology in Drug Development; Feb2024, Vol. 13 Issue 2, p208-218, 11p |
| Abstrakt: |
Tirbanibulin ointment 1% is approved in the United States and Europe for the treatment of actinic keratosis with demonstrated efficacy, safety, and tolerability when applied over a field up to 25 cm2. This Phase 1 maximal‐use trial determines the plasma pharmacokinetics, safety, and tolerability of tirbanibulin ointment 1% applied to 100 cm2 of the face or balding scalp in adults with actinic keratosis. Twenty‐eight patients self‐applied tirbanibulin once daily for a single 5‐day treatment course. On Day 5, the mean maximum plasma concentration was 1.06 ng/mL and area under the plasma concentration‐time curve during a dosing interval was 16.2 ng • h/mL. Systemic exposure was approximately 4‐fold higher than in a previous pharmacokinetic study with a 25 cm2 field, consistent with the increase in the treated area. Tirbanibulin applied to a 100‐cm2 treatment field showed favorable safety and tolerability. The most common treatment‐emergent adverse events were application site reactions (in 35.7% of patients). All treatment‐emergent adverse events and most of the tolerability signs were mild/moderate and resolved or returned to baseline by Day 29. In summary, under maximal‐use conditions, tirbanibulin ointment 1% was safe and well tolerated supporting its potential use over a field up to 100 cm2. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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