Effects of fermagate on the PK of digoxin in healthy volunteers

• Research type

  Research Study

• Full title

  A double blind, randomised, two period crossover study to determine the effect of multiple doses of fermagate on the on the pharmacokinetics of digoxin in healthy volunteers

• IRAS ID

  44624

• Contact name

  Simon Constable

• Sponsor organisation

  INEOS Healthcare Ltd

• Eudract number

  2009-017651-10

• ISRCTN Number

  NA

• Research summary

  The aim of this study is to investigate the effects of multiple doses of Fermagate on the efficacy, safety and tolerability of Digoxin. Fermagate is being developed to prevent hyperphosphataemia in patients with end stage renal disease (ESRD). Digoxin is likely to be co-administered to patients with ESRD as they have a high prevalence of ischaemic heart disease, hence any potential interaction between fermagate and Digoxin warrants investigation This is a single centre, double-blind, placebo controlled, randomised, 2-way crossover study. Each subject will participate in a screening period, two study periods and a follow-up period. Subjects will be randomised to receive Digoxin in combination with Fermagate in one study period and Digoxin with a placebo-to-match Fermagate in the alternate study period. Treatment with Fermagate or placebo in alternate periods will be double-blind; treatment with Digoxin in both study periods will be open-label. The effects of Fermagate on exposure to Digoxin will be examined by measuring Digoxin pharmacokinetics parameters in serum samples and urine collected up to 72 hours after dosing. Adverse events, clinical safety laboratory tests (haematology, serum biochemistry and urinalysis), electrocardiograms (ECGs) and vital signs (blood pressure and pulse) will be monitored at intervals during each study period to assess safety and tolerability. Potassium, magnesium and corrected calcium will be measured at additional timepoints. Subjects must be between 18 and 45 years inclusive and between 19 to 30 kg/m2 body mass index as well as have negative drugs of abuse, cotinine and alcohol tests at screening, have no significant surgical or family history, atopy, drug hypersensitivity or known infections and inflammatory process. Female subjects who are of child bearing potential must use reliable contraceptive methods and not be lactating or pregnant. Subjects must not use prescription drugs within 4 weeks and over the counter medication for 7 days prior to dosing.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC03/3

• Date of REC Opinion

  24 Mar 2010

• REC opinion

  Further Information Favourable Opinion