The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-13

Study Completion Date

2008-01-22

Brief Summary

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Age related differences in response to a drug could arise from variation in pharmacokinetic (PK) and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety profile of anagrelide is well established through a well-documented clinical trial programme in patients of all ages, no formal studies have been carried out to investigate whether the PK profile of anagrelide and its metabolites is altered with age.

This study is designed to allow comparisons to be made in terms of pharmacokinetics of anagrelide and its metabolites between elderly (≥ 65 years) and young (18-50 years) ET patients

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Detailed Description

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Conditions

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Essential Thrombocythaemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Younger Participants (18-50 years)

Group Type EXPERIMENTAL

anagrelide hydrochloride

Intervention Type DRUG

Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.

Elderly Participants (≥65 years)

Group Type EXPERIMENTAL

anagrelide hydrochloride

Intervention Type DRUG

Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.

Interventions

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anagrelide hydrochloride

Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.

Intervention Type DRUG

anagrelide hydrochloride

Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Young patients aged 18-50 years inclusive or Elderly patients aged 65 years and over
* Patients must have a confirmed diagnosis of ET.
* Currently receiving anagrelide hydrochloride at a stable maintenance dose \< 5 mg/day for at least 4 weeks.

Exclusion Criteria

* Diagnosis of any other myeloproliferative disorder.
* Current use of tobacco in any form (e.g. smoking or chewing)
* Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study.
* Patients for whom use of another cytoreductive agent in addition to anagrelide is considered necessary for control of platelet count.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No