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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Bilastine; Drug: Bilastine & Ketoconazole; Drug: Placebo; Drug: Moxifloxacin

• Registration Number: NCT00419783
• Lead Sponsor: Faes Farma, S.A.

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-08
• Study First Posted: 2007-01-09
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Bilastine	Bilastine 20 mg
3	Bilastine & Ketoconazole	Bilastine 20 mg + Ketoconazole 400 mg
5	Placebo	Placebo
2	Bilastine	Bilastine 100 mg
4	Moxifloxacin	Moxifloxacin 400 mg

Primary Outcome Measures

Name	Time	Method
QTc Interval prolongation	4 days

Secondary Outcome Measures

Name	Time	Method
vital signs, adverse events, and routine clinical laboratory tests	4 days

Trial Locations

Locations (1)

MDS Pharma Services; 🇺🇸 Phoenix, Arizona, United States