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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-29

Study Completion Date

2012-07-25

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anagrelide Therapeutic (0.5 mg)

Group Type EXPERIMENTAL

Anagrelide 0.5 mg

Intervention Type DRUG

0.5mg Anagrelide single oral dose

Anagrelide Supratherapeutic (2.5 mg)

Group Type EXPERIMENTAL

Anagrelide 2.5 mg

Intervention Type DRUG

2.5mg Anagrelide single oral dose

Moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

400 mg Moxifloxacin single oral dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Anagrelide placebo + Moxifloxacin placebo single oral dose

Interventions

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Anagrelide 0.5 mg

0.5mg Anagrelide single oral dose

Intervention Type DRUG

Anagrelide 2.5 mg

2.5mg Anagrelide single oral dose

Intervention Type DRUG

Moxifloxacin

400 mg Moxifloxacin single oral dose

Intervention Type DRUG

Placebo

Anagrelide placebo + Moxifloxacin placebo single oral dose

Intervention Type DRUG

Other Intervention Names

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Agrylin, Xagrid

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes