Effects of fermagate on the PK of levothyroxine 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 pharmacokinetics of levothyroxine in healthy subjects

• IRAS ID

  33435

• Contact name

  Simon Constable

• Sponsor organisation

  INEOS Healthcare Ltd

• Eudract number

  2009-017654-13

• 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 levothyroxine. Fermagate is being developed to prevent hyperphosphataemia in patients with end stage renal disease (ESRD). Levothyroxine is often prescribed to patients with ESRD with associated thyroid problems and hence any potential interaction between fermagate and levothyroxine 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 levothyroxine in combination with fermagate in one study period and levothyroxine 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 levothyroxine in both study periods will be open-label. The effects of fermagate on exposure to levothyroxine will be examined by measuring levothyroxine pharmacokinetics parameters (T3 and T4) in plasma samples 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/IEC03/2

• Date of REC Opinion

  3 Mar 2010

• REC opinion

  Further Information Favourable Opinion