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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00419783

Run by

Faes Farma, S.A.

People needed

30

Starts

2006-08-01

Expected to finish

2006-12-01

Last updated by the study team

2012-04-05

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy subjects with no clinically significant findings note on screening assessments including medical history, physical examination and laboratory results

You may not qualify if…

• 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

Where it is running

• MDS Pharma Services — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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