A Randomized, Multiple Dose, Double Blind, 5-Way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine
Information source: Faes Farma, S.A.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: bilastine (Drug); Bilastine (Drug); Bilastine & Ketoconazole (Drug); Moxifloxacin (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Faes Farma, S.A. Official(s) and/or principal investigator(s):
Mark J Allison, MD, Principal Investigator, Affiliation: MDS Pharma Services (US)
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study
Primary outcome: QTc Interval prolongation
Secondary outcome: vital signs, adverse events, and routine clinical laboratory tests
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
MDS Pharma Services, Phoenix, Arizona 85044, United States
Additional Information
Starting date: August 2006
Ending date: December 2006
Last updated: December 12, 2007
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