Phase 2
N=24
The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)
Essential Thrombocythaemia
Bottom Line
View on ClinicalTrials.gov: NCT00413634 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcome: Primary: Maximum Plasma Concentration (Cmax) of Agrylin — 2.66; 3.63 ng/ml — p=0.092
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- anagrelide hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of Agrylin |
2.66; 3.63 | 0.092 |
| PRIMARY Time of Maximum Plasma Concentration (Tmax) of Agrylin |
1.11; 1.14 | 0.857 |
| PRIMARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin |
6.4; 10.3 | 0.013 sig |
| PRIMARY Terminal Half-life (T 1/2) of Agrylin |
1.3; 1.4 | 0.378 |
| PRIMARY Total Clearance (CL/F) of Agrylin |
156; 97 | 0.013 sig |
| PRIMARY Volume of Distribution (Vz/F) of Agrylin |
286; 195 | 0.035 sig |
| PRIMARY Cmax of Active Metabolite |
7.26; 4.19 | 0.023 sig |
| PRIMARY Tmax of Active Metabolite |
0.92; 1.04 | 0.557 |
| PRIMARY AUC of Active Metabolite |
27.6; 17.4 | 0.027 sig |
| PRIMARY T 1/2 of Active Metabolite |
2.7; 3.5 | 0.007 sig |
| PRIMARY CL/F of Active Metabolite |
36; 57 | 0.027 sig |
| PRIMARY Vz/F of Active Metabolite |
139; 277 | 0.011 sig |
| SECONDARY Platelet Count |
488.8; 548.5; 487.9; 539.2; 473.2; 540.3 | — |
| SECONDARY Heart Rate |
74.0; 70.3; 72.4; 77.7; 75.8; 80.6 | — |
| SECONDARY Systolic Blood Pressure |
122.2; 154.3; 122.7; 145.2; 121.8; 143.7 | — |
| SECONDARY Diastolic Blood Pressure |
76.9; 81.4; 74.8; 75.2; 72.4; 72.6 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT00413634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.