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

Faes Farma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Moxifloxacin; Drug: bilastine; Drug: Bilastine & Ketoconazole; Drug: Placebo; Drug: Bilastine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419783

AA24101

459-09

BILA-459/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

30 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

Bilastine 20 mg

Treatment:

Drug: bilastine

2

Experimental group

Description:

Bilastine 100 mg

Treatment:

Drug: Bilastine

3

Active Comparator group

Description:

Bilastine 20 mg + Ketoconazole 400 mg

Treatment:

Drug: Bilastine & Ketoconazole

4

Active Comparator group

Description:

Moxifloxacin 400 mg

Treatment:

Drug: Moxifloxacin

5

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo