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.
Overview
- Phase
- Phase 2
- Intervention
- anagrelide hydrochloride
- Conditions
- Essential Thrombocythaemia
- Sponsor
- Shire
- Enrollment
- 24
- Locations
- 5
- Primary Endpoint
- AUC of Active Metabolite
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
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.
Arms & Interventions
Younger Participants (18-50 years)
Intervention: anagrelide hydrochloride
Elderly Participants (≥65 years)
Intervention: anagrelide hydrochloride
Outcomes
Primary Outcomes
AUC of Active Metabolite
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
Total Clearance (CL/F) of Agrylin
Time Frame: over 1 day
Terminal Half-life (T 1/2) of Agrylin
Time Frame: over 1 day
Volume of Distribution (Vz/F) of Agrylin
Time Frame: over 1 day
Vz/F of Active Metabolite
Time Frame: over 1 day
Maximum Plasma Concentration (Cmax) 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
T 1/2 of Active Metabolite
Time Frame: over 1 day
CL/F of Active Metabolite
Time Frame: over 1 day
Secondary Outcomes
- Systolic Blood Pressure(over 1 day)
- Diastolic Blood Pressure(over 1 day)
- Heart Rate(over 1 day)
- Platelet Count(over 1 day)