LEO 22811 – A Single Dose Bioavailability Study

• Research type

  Research Study

• Full title

  LEO 22811 – A Single Dose Bioavailability Study of Oral Solid Dosage Form versus Oral Solution Including Fed versus Fasted State in Healthy Male Subjects

• IRAS ID

  58659

• Contact name

  Ashley Brooks

• Sponsor organisation

  LEO Pharma A/S

• Eudract number

  2010-018388-41

• Research summary

  LEO Pharma is developing a new drug to treat psoriasis. Psoriasis is one of the most common chronic skin diseases. An estimated 122 million people world-wide have psoriasis, of which 25-30% are thought to have moderate to severe disease. Psoriatic skin is characterised by thickened, red and scaly skin, which may itch. It is intended that this drug, as part of a new generation of highly selective p38 inhibitors under development will offer advantages over existing treatments in terms of improving the benefit/risk ratio. LEO 22811 is therefore expected to give a broad anti-inflammatory activity including the inhibition of a cytokine shown to be a central player in psoriasis. LEO 22811 has been administered to 58 healthy male volunteers in single and multiple oral doses as a solution. Thirty four subjects in the fasted state received single oral doses of LEO 22811 and were considered safe at increasing doses of up to 16 mg. In addition LEO 22811 was also tested in the fed state and was found to be safe and well tolerated. This current study will help us to assess how much of the study drug actually reaches the body??s circulation in a fed and fasted state. It will also measure how different formulations such as the solution and tablet affect the amount of study drug in the blood. Fifteen subjects will be studied with each subject participating in three treatment periods. Each subject will receive the three treatments below (one in each treatment period): ?½ LEO 22811 oral solution 1.5 mg (fasted state) ?½ LEO 22811 single tablet 1.5 mg (fasted state) ?½ LEO 22811 single tablet 1.5 mg (fed state) The order in which subjects will receive the treatments will be determined randomly (by chance, like flipping a coin).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/20

• Date of REC Opinion

  9 Sep 2010

• REC opinion

  Further Information Favourable Opinion