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

Shire

Status and phase

Completed

Phase 2

Conditions

Essential Thrombocythaemia

Treatments

Drug: anagrelide hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413634

SPD422-203

2004-004058-20 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.