A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1, Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic Effects of Bilastine in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: bilastine
* Drug: Bilastine
* Drug: Bilastine & Ketoconazole
* Drug: Moxifloxacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects with no clinically significant findings note on screening assessments including medical history, physical examination and laboratory results Exclusion Criteria: Clinically significant medical condition Clinically significant history of ECG abnormalities or family history of QTc interval syndrome Use of tobacco and/or nicotine products >3 months prior to screening Use of any prescription medications within 14 days prior to screening Use of over the counter medications (including herbal products) within 7 days prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bilastine 20 mg | Drug: bilastine<br>* 20 mg tablets.<br>|
| Experimental: 2<br>Bilastine 100 mg | Drug: Bilastine<br>* 100 mg (5 tablets of 20 mg)<br>|
| Active Comparator: 3<br>Bilastine 20 mg + Ketoconazole 400 mg | Drug: Bilastine & Ketoconazole<br>* 1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet<br>|
| Active Comparator: 4<br>Moxifloxacin 400 mg | Drug: Moxifloxacin<br>* 1 capsule containing moxifloxacin 400 mg tablet<br>|
| Placebo Comparator: 5<br>Placebo | Drug: Placebo<br>* Placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc Interval prolongation |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs, adverse events, and routine clinical laboratory tests |  | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinitis, Urticaria