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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Faes Farma, S.A.
ClinicalTrials.gov Identifier:
NCT00419783
First received: January 8, 2007
Last updated: April 4, 2012
Last verified: April 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014