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

This study has been completed.
Information provided by (Responsible Party):
Faes Farma, S.A. Identifier:
First received: January 8, 2007
Last updated: April 4, 2012
Last verified: April 2012

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.

Condition Intervention Phase
Drug: bilastine
Drug: Bilastine
Drug: Bilastine & Ketoconazole
Drug: Moxifloxacin
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic Effects of Bilastine in Healthy Adult Subjects

Resource links provided by NLM:

Further study details as provided by Faes Farma, S.A.:

Primary Outcome Measures:
  • QTc Interval prolongation [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • vital signs, adverse events, and routine clinical laboratory tests [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: August 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bilastine 20 mg
Drug: bilastine
20 mg tablets.
Experimental: 2
Bilastine 100 mg
Drug: Bilastine
100 mg (5 tablets of 20 mg)
Active Comparator: 3
Bilastine 20 mg + Ketoconazole 400 mg
Drug: Bilastine & Ketoconazole
1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet
Active Comparator: 4
Moxifloxacin 400 mg
Drug: Moxifloxacin
1 capsule containing moxifloxacin 400 mg tablet
Placebo Comparator: 5
Drug: Placebo
Placebo tablets

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.


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00419783

United States, Arizona
MDS Pharma Services
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
Faes Farma, S.A.
Principal Investigator: Mark J Allison, MD MDS Pharma Services (US)
  More Information

Responsible Party: Faes Farma, S.A. Identifier: NCT00419783     History of Changes
Other Study ID Numbers: 459-09, BILA-459/09, AA24101
Study First Received: January 8, 2007
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Faes Farma, S.A.:
Allergic rhinitis

Additional relevant MeSH terms:
14-alpha Demethylase Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on March 01, 2015