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

Phase 2

Completed

• Conditions: Essential Thrombocythaemia
• Interventions: Drug: anagrelide hydrochloride

• Registration Number: NCT00413634
• Lead Sponsor: Shire

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-13
• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-20
• Primary Completion: 2008-01-22
• Study Completion: 2008-01-22
• Results First Submitted: 2009-03-05
• Results First Submitted QC: 2009-04-08
• Results First Posted: 2009-06-02
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elderly Participants (≥65 years)	anagrelide hydrochloride	-
Younger Participants (18-50 years)	anagrelide hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Time of Maximum Plasma Concentration (Tmax) of Agrylin	over 1 day
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin	over 1 day
Total Clearance (CL/F) of Agrylin	over 1 day
AUC of Active Metabolite	over 1 day
Terminal Half-life (T 1/2) of Agrylin	over 1 day
Volume of Distribution (Vz/F) of Agrylin	over 1 day
Vz/F of Active Metabolite	over 1 day
Maximum Plasma Concentration (Cmax) of Agrylin	over 1 day
Cmax of Active Metabolite	over 1 day	An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.
Tmax of Active Metabolite	over 1 day
T 1/2 of Active Metabolite	over 1 day
CL/F of Active Metabolite	over 1 day

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	over 1 day	Systolic blood pressures in patients with ET receiving Agrylin
Diastolic Blood Pressure	over 1 day	Diastolic blood pressures in patients with ET receiving Agrylin
Heart Rate	over 1 day	Heart rates in patients with ET receiving Agrylin
Platelet Count	over 1 day	Platelet counts in patients with ET receiving Agrylin

Trial Locations

Locations (5)

Hospitl Del Mar; 🇪🇸 Barcelona, Spain

Quintiles Hermelinen; 🇸🇪 Lulea, Sweden

Uppsala Akademiska Sjukhus; 🇸🇪 Uppsala, Sweden

Quintiles AB Phase I Unit; 🇸🇪 Uppsala, Sweden

Belfast City Hospital; 🇬🇧 Belfast, United Kingdom