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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-12-31

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Bilastine 20 mg

Group Type EXPERIMENTAL

bilastine

Intervention Type DRUG

20 mg tablets.

2

Bilastine 100 mg

Group Type EXPERIMENTAL

Bilastine

Intervention Type DRUG

100 mg (5 tablets of 20 mg)

3

Bilastine 20 mg + Ketoconazole 400 mg

Group Type ACTIVE_COMPARATOR

Bilastine & Ketoconazole

Intervention Type DRUG

1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet

4

Moxifloxacin 400 mg

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

1 capsule containing moxifloxacin 400 mg tablet

5

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets

Interventions

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bilastine

20 mg tablets.

Intervention Type DRUG

Bilastine

100 mg (5 tablets of 20 mg)

Intervention Type DRUG

Bilastine & Ketoconazole

1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet

Intervention Type DRUG

Moxifloxacin

1 capsule containing moxifloxacin 400 mg tablet

Intervention Type DRUG

Placebo

Placebo tablets

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes