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Completed

NCT Number: NCT01552928

Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers

According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated for their ability to prolong the QT interval which represents the duration of ventricular depolarization and subsequent repolarization. The primary objective of the study is to assess the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose of anagrelide when compared to placebo and a positive control.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biotrial

Rueil-Malmaison, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-45 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the screening period. This inclusion criteria will only be assessed at the screening visit.
  • Subject is willing to comply with any applicable contraceptive requirements of the protocol and is: male, or non-pregnant non lactating female, or females must be at least 90 days post-partum or nulliparous.
  • Satisfactory medical assessment with no clinically or relevant abnormalities in medical history, physical examination, vital signs, ECG, and clinical laboratory evaluation as assessed by the investigator.

Exclusion criteria

  • Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments.

a- Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.

  • Significant illness, as judged by the Investigator, within 2 weeks of the first dose of investigational product.

Treatment and study plan

Anagrelide 0.5 mg

Drug

0.5mg Anagrelide single oral dose

Other names: Agrylin, Xagrid

Anagrelide 2.5 mg

Drug

2.5mg Anagrelide single oral dose

moxifloxacin

Drug

400 mg Moxifloxacin single oral dose

Placebo

Drug

Anagrelide placebo + Moxifloxacin placebo single oral dose

Primary outcomes

  1. Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point

    Time frame: Over 12 hours post-dose

    QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.

  2. Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point

    Time frame: Over 12 hours post-dose

    The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.

  3. Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point

    Time frame: Over 12 hours post-dose

    QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.

  4. Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point

    Time frame: Over 12 hours post-dose

    QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.

  5. Mean Difference Changes From Baseline Versus Placebo in QT Intervals From Time-Matched Analysis by Largest Time Point

    Time frame: Over 12 hours post-dose

    The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.

Secondary outcomes

  1. Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax)

    Time frame: Over 12 hours post-dose

    QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.

  2. Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax

    Time frame: Over 12 hours post-dose

  3. Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax

    Time frame: Over 12 hours post-dose

    QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.

  4. Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax

    Time frame: Over 12 hours post-dose

    QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.

  5. Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax

    Time frame: Over 12 hours post-dose

    The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.

  6. Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females

    Time frame: Over 12 hours post-dose

  7. Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females

    Time frame: Over 12 hours post-dose

  8. Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females

    Time frame: Over 12 hours post-dose

  9. Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females

    Time frame: Over 12 hours post-dose

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, 4-Period Crossover Trial to Assess the Effect of Anagrelide Hydrochloride on QT/QTc Interval in Healthy Men and Women.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 13, 2012
Registry last updated
Jun 9, 2021

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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