drugset / Trial / NCT00419783
A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine
RandomizedCrossoverQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the effect of two doses of bilastine (20 and 100 mg) compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and placebo. Subjects will receive each of the five study treatments in a crossover fashion administered once daily for 4 days.
Timeline
- Start
- 2006-08
- Primary completion
- 2006-12
- Completion
- 2006-12
Publications
- Background Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11.
- Results Tyl B, Kabbaj M, Azzam S, Sologuren A, Valiente R, Reinbolt E, Roupe K, Blanco N, Wheeler W. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol. 2012 Jun;52(6):893-903. doi: 10.1177/0091270011407191. Epub 2011 Jun 3.
- Results Graff C, Struijk JJ, Kanters JK, Andersen MP, Toft E, Tyl B. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig. 2012 May 1;32(5):339-51. doi: 10.2165/11599270-000000000-00000.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bilastine | Small molecule | 20 mg | — |
| Subject | Bilastine | Small molecule | 100 mg | — |
| Comparator | Ketoconazole | Small molecule | 400 mg | — |
| Comparator | Moxifloxacin | Small molecule | 400 mg | — |
Indications
No indication recorded.