Clinical trial NCT00413634: The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)
Official title: A Phase II, Open-label, Multicentre, Pharmacokinetic, Pharmacodynamic and Safety Study of Anagrelide Hydrochloride in Young (18-50 Years) and Elderly (≥ 65 Years) Patients With Essential Thrombocythaemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Thrombocythaemia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-12-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Agrylin
timeFrame: over 1 day
measure: Time of Maximum Plasma Concentration (Tmax) of Agrylin
timeFrame: over 1 day
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin
timeFrame: over 1 day
measure: Terminal Half-life (T 1/2) of Agrylin
timeFrame: over 1 day
measure: Total Clearance (CL/F) of Agrylin
timeFrame: over 1 day
measure: Volume of Distribution (Vz/F) of Agrylin
timeFrame: over 1 day
measure: Cmax of Active Metabolite
timeFrame: over 1 day
measure: Tmax of Active Metabolite
timeFrame: over 1 day
measure: AUC of Active Metabolite
timeFrame: over 1 day
measure: T 1/2 of Active Metabolite
timeFrame: over 1 day
measure: CL/F of Active Metabolite
timeFrame: over 1 day
measure: Vz/F of Active Metabolite
timeFrame: over 1 day
Secondary outcomes:
measure: Platelet Count
timeFrame: over 1 day
measure: Heart Rate
timeFrame: over 1 day
measure: Systolic Blood Pressure
timeFrame: over 1 day
measure: Diastolic Blood Pressure
timeFrame: over 1 day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospitl Del Mar
city: Lulea
country: Sweden
facility: Quintiles Hermelinen
city: Uppsala
country: Sweden
facility: Uppsala Akademiska Sjukhus
city: Uppsala
country: Sweden
facility: Quintiles AB Phase I Unit
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Besses C, Zeller W, Alvarez-Larran A, Coll R, Troy S, Purkayastha J, Martin P, Freitag C. Pharmacokinetics and tolerability of anagrelide hydrochloride in young (18 - 50 years) and elderly (>/= 65 years) patients with essential thrombocythemia. Int J Clin Pharmacol Ther. 2012 Nov;50(11):787-96. doi: 10.5414/CP201711.