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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 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 Summary:
Sponsor: Shire

Current Primary Outcome:

  • 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 [ Time Frame: 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 [ 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 ]


Original Primary Outcome: Single day PK assessments of anagrelide and metabolite.

Current Secondary Outcome:

  • Platelet Count [ Time Frame: over 1 day ]
    Platelet counts in patients with ET receiving Agrylin
  • Heart Rate [ Time Frame: over 1 day ]
    Heart rates in patients with ET receiving Agrylin
  • Systolic Blood Pressure [ Time Frame: over 1 day ]
    Systolic blood pressures in patients with ET receiving Agrylin
  • Diastolic Blood Pressure [ Time Frame: over 1 day ]
    Diastolic blood pressures in patients with ET receiving Agrylin


Original Secondary Outcome:

  • Correlation of daily dose, anagrelide plasma concentrations and changes from baseline in platelet count.
  • Correlation of plasma concentration of anagrelide and its active metabolite and heart rate and blood pressure.
  • Safety and tolerability


Information By: Shire

Dates:
Date Received: December 19, 2006
Date Started: August 2006
Date Completion:
Last Updated: June 6, 2014
Last Verified: July 2010