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

Essential Thrombocythaemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413634
• Other study ID #: SPD422-203
• Secondary ID: 2004-004058-20
• Status: Completed
• Phase: Phase 2
• Start date: November 13, 2006
• Est. completion date: January 22, 2008

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 22, 2008
• Est. primary completion date: January 22, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Thrombocythaemia
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Hospitl Del Mar	Barcelona
Sweden	Quintiles Hermelinen	Lulea
Sweden	Quintiles AB Phase I Unit	Uppsala
Sweden	Uppsala Akademiska Sjukhus	Uppsala
United Kingdom	Belfast City Hospital	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) of Agrylin		over 1 day
Primary	Time of Maximum Plasma Concentration (Tmax) of Agrylin		over 1 day
Primary	Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin		over 1 day
Primary	Terminal Half-life (T 1/2) of Agrylin		over 1 day
Primary	Total Clearance (CL/F) of Agrylin		over 1 day
Primary	Volume of Distribution (Vz/F) of Agrylin		over 1 day
Primary	Cmax of Active Metabolite	An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.	over 1 day
Primary	Tmax of Active Metabolite		over 1 day
Primary	AUC of Active Metabolite		over 1 day
Primary	T 1/2 of Active Metabolite		over 1 day
Primary	CL/F of Active Metabolite		over 1 day
Primary	Vz/F of Active Metabolite		over 1 day
Secondary	Platelet Count	Platelet counts in patients with ET receiving Agrylin	over 1 day
Secondary	Heart Rate	Heart rates in patients with ET receiving Agrylin	over 1 day
Secondary	Systolic Blood Pressure	Systolic blood pressures in patients with ET receiving Agrylin	over 1 day
Secondary	Diastolic Blood Pressure	Diastolic blood pressures in patients with ET receiving Agrylin	over 1 day

External Links

•   FDA Recall Information
•   FDA-approved Label