An open-label, randomised crossover pharmacokinetic, palatability and safety study to assess the bioavailability of 5ml of a new 6MP oral liquid formulation by comparison to a currently registered 6MP 50 mg (Purinethol) adult tablet (part A) followed by an open, non-randomised multiple-doses study with adjusted doses of 6MP oral liquid formulation (part B) in children with Acute Lymphoblastic Leukaemia.
Phase of Trial: Phase I
Latest Information Update: 01 Jun 2013
At a glance
- Drugs Mercaptopurine (Primary)
- Indications Precursor cell lymphoblastic leukaemia-lymphoma
- Focus Adverse reactions; Pharmacogenomic; Pharmacokinetics
- 28 Apr 2012 Additional trial location (Germany) identified as reported by European Clinical Trials Database.
- 15 Jun 2011 New trial record