Healthy
Conditions
Keywords
Allergic rhinitis, Urticaria
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.
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.
Interventions
Sponsors
Faes Farma, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QTc Interval prolongation | 4 days |
Secondary
| Measure | Time frame |
|---|---|
| vital signs, adverse events, and routine clinical laboratory tests | 4 days |
Countries
United States
Outcome results
None listed