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Completed

NCT Number: NCT00413634

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

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

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Key information

Conditions

Essential Thrombocythaemia Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Myeloproliferative Disorders Thrombocythemia, Essential Thrombocytosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospitl Del Mar, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anagrelide hydrochloride

Drug

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.

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of Agrylin

    Time frame: over 1 day

  2. Time of Maximum Plasma Concentration (Tmax) of Agrylin

    Time frame: over 1 day

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

    Time frame: over 1 day

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

    Time frame: over 1 day

  5. Total Clearance (CL/F) of Agrylin

    Time frame: over 1 day

  6. Volume of Distribution (Vz/F) of Agrylin

    Time frame: over 1 day

  7. 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.

  8. Tmax of Active Metabolite

    Time frame: over 1 day

  9. AUC of Active Metabolite

    Time frame: over 1 day

  10. T 1/2 of Active Metabolite

    Time frame: over 1 day

  11. CL/F of Active Metabolite

    Time frame: over 1 day

  12. Vz/F of Active Metabolite

    Time frame: over 1 day

Secondary outcomes

  1. Platelet Count

    Time frame: over 1 day

    Platelet counts in patients with ET receiving Agrylin

  2. Heart Rate

    Time frame: over 1 day

    Heart rates in patients with ET receiving Agrylin

  3. Systolic Blood Pressure

    Time frame: over 1 day

    Systolic blood pressures in patients with ET receiving Agrylin

  4. Diastolic Blood Pressure

    Time frame: over 1 day

    Diastolic blood pressures in patients with ET receiving Agrylin

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 20, 2006
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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