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

April 4, 2012 updated by: Faes Farma, S.A.

A Phase 1, Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic Effects of Bilastine in Healthy Adult Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 5
Placebo
Drug: Placebo
Placebo tablets
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QTc Interval prolongation
Time Frame: 4 days
4 days

Secondary Outcome Measures

Outcome Measure
Time Frame
vital signs, adverse events, and routine clinical laboratory tests
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faes Farma, S.A.

Investigators

  • Principal Investigator: Mark J Allison, MD, MDS Pharma Services (US)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

January 8, 2007

First Submitted That Met QC Criteria

January 8, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

April 5, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 459-09
  • BILA-459/09
  • AA24101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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