Overview

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

Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Faes Farma, S.A.
Treatments:
Ketoconazole
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Criteria
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