valuation of Eprotirome on the PK and PD of a single dose of Warfarin

• Research type

  Research Study

• Full title

  AN OPEN LABEL, 2-WAY CROSSOVER STUDY TO EVALUATE THE STEADY-STATE EFFECT OF EPROTIROME ON THE PHARMACOKINETICS AND PHARMACODYNAMICS OF A SINGLE DOSE OF WARFARIN IN HEALTHY SUBJECTS

• IRAS ID

  85029

• Sponsor organisation

  Karo Bio AB

• Eudract number

  2011-003029-92

• Research summary

  This study will evaluate the effect of eprotirome at steady-state on the pharmacokinetics (PK) and pharmacodynamics (PK) of a single supratherapeutic dose of the anti-coagulant Warfarin in healthy subjects. Eprotirome is an orally dosed thyroid hormone analogue which is preferentially distributed to the liver, and causes lowering of blood lipids which are known risk factors of cardiovascular disease. It seems likely that many patients may use eprotirome together with Warfarin. The objective is to assess whether eprotirome treatment could affect the required therapeutic dose of Warfarin. An randomized sequence, open-label, two-way crossover design will be applied where two groups, each with 7 subjects of both gender (3-4 females per group), will be subjected to the following:Group 1?½ A single, oral dose of 25 mg warfarin is given on Day 1?½ PK and PD is measured in blood samples drawn on Days 1-8?½ 100 æg eprotirome is given orally once daily for 21 days from Days 8-28, with a single, oral dose of 25 mg warfarin co-administered on Day 22?½ PK and PD is measured in blood samples Days 22-29?½ A follow-up visit on Day 42.Group 2 ?½ 100 æg eprotirome is given once daily for 21 days from Days 0-20, with a single, oral dose of 25 mg warfarin co-administered on Day 14?½ PK and PD is measured in blood samples drawn on Days 14-21?½ A 14 day wash-out (ie no administration of medication) Days 21-34?½ A single, oral dose of 25 mg warfarin is given on Day 35?½ PK and PD is measured in blood samples Days 35-42?½ A follow-up visit on Day 42

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0120

• Date of REC Opinion

  5 Sep 2011

• REC opinion

  Further Information Favourable Opinion