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Completed

NCT Number: NCT00419783

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MDS Pharma Services

Phoenix, Arizona, 85044, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilastine

Drug

20 mg tablets.

Bilastine & Ketoconazole

Drug

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

moxifloxacin

Drug

1 capsule containing moxifloxacin 400 mg tablet

Placebo

Drug

Placebo tablets

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

Sponsors and collaborators

Lead sponsor

Faes Farma, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 9, 2007
Registry last updated
Apr 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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