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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00419783
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : April 5, 2012
Information provided by (Responsible Party):
Faes Farma, S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: bilastine Drug: Bilastine Drug: Bilastine & Ketoconazole Drug: Moxifloxacin Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. QTc Interval prolongation [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. vital signs, adverse events, and routine clinical laboratory tests [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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)

Publications of Results:
Other Publications:
Responsible Party: Faes Farma, S.A. Identifier: NCT00419783     History of Changes
Other Study ID Numbers: 459-09
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP3A Inhibitors