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

Shire24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Essential Thrombocythaemia

Interventions

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.

anagrelide hydrochlorideDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Hospitl Del Mar

Barcelona, Spain

Quintiles Hermelinen

Luleå, Sweden

Uppsala Akademiska Sjukhus

Uppsala, Sweden

Quintiles AB Phase I Unit

Uppsala, Sweden

Belfast City Hospital

Belfast, United Kingdom

Outcomes

Primary Outcomes

Maximum Plasma Concentration (Cmax) of Agrylin

Time frame: over 1 day

Time of Maximum Plasma Concentration (Tmax) of Agrylin

Time frame: over 1 day

Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin

Time frame: over 1 day

Terminal Half-life (T 1/2) of Agrylin

Time frame: over 1 day

Total Clearance (CL/F) of Agrylin

Time frame: over 1 day

Volume of Distribution (Vz/F) of Agrylin

Time frame: over 1 day

Cmax of Active Metabolite

An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.

Time frame: over 1 day

Tmax of Active Metabolite

Time frame: over 1 day

AUC of Active Metabolite

Time frame: over 1 day

T 1/2 of Active Metabolite

Time frame: over 1 day

CL/F of Active Metabolite

Time frame: over 1 day

Vz/F of Active Metabolite

Time frame: over 1 day

Secondary Outcomes

Platelet Count

Platelet counts in patients with ET receiving Agrylin

Time frame: over 1 day

Heart Rate

Heart rates in patients with ET receiving Agrylin

Time frame: over 1 day

Systolic Blood Pressure

Systolic blood pressures in patients with ET receiving Agrylin

Time frame: over 1 day

Diastolic Blood Pressure

Diastolic blood pressures in patients with ET receiving Agrylin

Time frame: over 1 day