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| ID | Type | Description | Link |
|---|---|---|---|
| BILA-459/09 | |||
| AA24101 |
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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.
This is a single center, Phase 1 study that utilizes a randomized, multiple-dose, double-blind, 5-way crossover design with a placebo control and two active controls. A minimum seven day washout period following four days of dosing for each of the five treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bilastine 20 mg |
|
| 2 | Experimental | Bilastine 100 mg |
|
| 3 | Active Comparator | Bilastine 20 mg + Ketoconazole 400 mg |
|
| 4 | Active Comparator | Moxifloxacin 400 mg |
|
| 5 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bilastine | Drug | 20 mg tablets. |
| |
| Bilastine |
| Measure | Description | Time Frame |
|---|---|---|
| QTc Interval prolongation | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| vital signs, adverse events, and routine clinical laboratory tests | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Allison, MD | MDS Pharma Services (US) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services | Phoenix | Arizona | 85044 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21831011 | 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. | |
| 21642470 | Result | 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. |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C445659 | bilastine |
| D007654 | Ketoconazole |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
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| Drug |
100 mg (5 tablets of 20 mg) |
|
| Bilastine & Ketoconazole | Drug | 1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet |
|
| Moxifloxacin | Drug | 1 capsule containing moxifloxacin 400 mg tablet |
|
| Placebo | Drug | Placebo tablets |
|
| 22393898 | Result | 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. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D042462 |
| 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |