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

Purpose

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
Healthy	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:

Drug Information available for: Ketoconazole Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

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 Placebo	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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419783

Locations

United States, Arizona
MDS Pharma Services
Phoenix, Arizona, United States, 85044

Sponsors and Collaborators

Faes Farma, S.A.

Investigators

Principal Investigator:

Mark J Allison, MD

MDS Pharma Services (US)

More Information

Publications:

Tyl B, Kabbaj M, Azzam S, Sologuren A, Valiente R, Reinbolt E, Roupe K, Blanco N, Wheeler W. Lack of Significant Effect of Bilastine Administered at Therapeutic and Supratherapeutic Doses and Concomitantly With Ketoconazole on Ventricular Repolarization: Results of a Thorough QT Study (TQTS) With QT-Concentration Analysis. J Clin Pharmacol. 2011 Jun 3. [Epub ahead of print]

Graff C, Struijk JJ, Kanters JK, Andersen MP, Toft E, Tyl B. Effects of Bilastine on T-wave Morphology and the QTc Interval: A Randomized, Double-Blind, Placebo-Controlled, Thorough QTc Study. Clin Drug Investig. 2012 Mar 6. doi: 10.2165/11599270-000000000-00000. [Epub ahead of print]

Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. Epub 2011 Aug 11. Review. Erratum in: Expert Opin Drug Saf. 2012 Jan;11(1):175.

Responsible Party:	Faes Farma, S.A.
ClinicalTrials.gov 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
Urticaria

Additional relevant MeSH terms:

Ketoconazole
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents

Anti-Infective Agents
Therapeutic Uses
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013