NCT00419783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

4 months

First QC Date

January 8, 2007

Last Update Submit

April 4, 2012

Conditions

Healthy

Keywords

Allergic rhinitisUrticaria

Outcome Measures

Primary Outcomes (1)

  • QTc Interval prolongation

    4 days

Secondary Outcomes (1)

  • vital signs, adverse events, and routine clinical laboratory tests

    4 days

Study Arms (5)

1

EXPERIMENTAL

Bilastine 20 mg

Drug: bilastine

2

EXPERIMENTAL

Bilastine 100 mg

Drug: Bilastine

3

ACTIVE COMPARATOR

Bilastine 20 mg + Ketoconazole 400 mg

Drug: Bilastine & Ketoconazole

4

ACTIVE COMPARATOR

Moxifloxacin 400 mg

Drug: Moxifloxacin

5

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

BilastineDRUG

20 mg tablets.

1
Bilastine & KetoconazoleDRUG

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

3
MoxifloxacinDRUG

1 capsule containing moxifloxacin 400 mg tablet

4
PlaceboDRUG

Placebo tablets

5

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services

Phoenix, Arizona, 85044, United States

Location

Related Publications (3)

  • 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.

    PMID: 21831011BACKGROUND

  • 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.

    PMID: 21642470RESULT

  • 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.

    PMID: 22393898RESULT

MeSH Terms

Conditions

Rhinitis, AllergicUrticaria

Interventions

bilastineKetoconazoleMoxifloxacin

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mark J Allison, MD

    MDS Pharma Services (US)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 9, 2007

Study Start

August 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

April 5, 2012

Record last verified: 2012-04

Locations

US(1)