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CompletedNCT00419783Updated Apr 5, 2012

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

A Phase 1 interventional study of bilastine and Bilastine in Healthy, sponsored by Faes Farma, S.A.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-05.

Sponsored by Faes Farma, S.A. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Allergic rhinitis
  • Urticaria
03

In context

Rhinitis, Allergic

1,042 studies on the registry are indexed under Rhinitis, Allergic; 91 are open to participants now.

This study's enrollment of 30 is below the median of 90 across 858 interventional studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Faes Farma, S.A. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy subjects with no clinically significant findings note on screening assessments including medical history, physical examination and laboratory results

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    1

    Bilastine 20 mg

    Drug: bilastine

  • Experimental
    2

    Bilastine 100 mg

    Drug: Bilastine

  • Active comparator
    3

    Bilastine 20 mg + Ketoconazole 400 mg

    Drug: Bilastine & Ketoconazole

  • Active comparator
    4

    Moxifloxacin 400 mg

    Drug: Moxifloxacin

  • Placebo comparator
    5

    Placebo

    Drug: Placebo

Interventions

  • Drugbilastine

    20 mg tablets.

  • DrugBilastine

    100 mg (5 tablets of 20 mg)

  • DrugBilastine & Ketoconazole

    Drug pages: Bilastine · Ketoconazole

    1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet

  • DrugMoxifloxacin

    1 capsule containing moxifloxacin 400 mg tablet

  • DrugPlacebo

    Placebo tablets

06

What researchers measure

Primary outcomes

  1. QTc Interval prolongation

    Time frame: 4 days

Secondary outcomes

  1. vital signs, adverse events, and routine clinical laboratory tests

    Time frame: 4 days

07

Study locations

1 site
  • MDS Pharma Services
    Phoenix, Arizona 85044, United States
08

References and documents

Publications

  • Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11. PubMed 21831011 ↗
  • Tyl B, Kabbaj M, Azzam S, Sologuren A, Valiente R, Reinbolt E, Roupe K, Blanco N, Wheeler W. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol. 2012 Jun;52(6):893-903. doi: 10.1177/0091270011407191. Epub 2011 Jun 3. PubMed 21642470 ↗
  • Graff C, Struijk JJ, Kanters JK, Andersen MP, Toft E, Tyl B. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig. 2012 May 1;32(5):339-51. doi: 10.2165/11599270-000000000-00000. PubMed 22393898 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2006, a primary completion of Dec 2006 and a completion of Dec 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2007
First posted
Jan 9, 2007
Start
Aug 2006
Primary completionActual
Dec 2006
CompletionActual
Dec 2006
Last update
Apr 5, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00419783
Lead sponsor
Faes Farma, S.A.
Responsible party
Sponsor
First posted
Jan 9, 2007
Start date
Aug 2006
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Apr 5, 2012

Study contacts

Mark J Allison, MD
principal investigator · MDS Pharma Services (US)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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