LEO 27847-K01 (Covance 8225188) Relative Bioavailability Study

• Research type

  Research Study

• Full title

  LEO 27847 – A Single Dose Bioavailability Study of Oral Solid Dosage Form versus Oral Solution Including Fed versus Fasted State in Healthy Male Subjects

• IRAS ID

  53141

• Contact name

  Joseph Chiesa

• Sponsor organisation

  LEO Pharma A/S

• Eudract number

  2010-019686-29

• Research summary

  LEO Pharma is developing LEO 27847 for use in the treatment of secondary Hyperparathyroidism (sHPT). This condition is caused by excessive secretion of the Parathyroid hormone (PTH) when calcium levels are low in the body. It is commonly seen in subjects with chronic renal failure in which low calcium levels in the blood stimulates the parathyroid glands to secrete PTH which then increases calcium levels in the blood. This leads to weakening of the bones as calcium is reabsorbed from the bones. LEO 27847 is a new member to a class of drugs called the ??calcimimetics?? which act on the calcium sensing receptors present in various tissues including the parathyroid gland. This reduces PTH secretion and has been shown to be effective in preventing the adverse effects of sHPT. It is hoped that LEO 27847 will be absorbed by the body and be available to a greater degree, have a reduced risk of interaction with other drugs and have a greater effectiveness and safety compared to the first-in-class (or first generation) calcimimetic, Cinacalcet. LEO 27847 has been administered to 42 healthy volunteers in a previous study as a solution. In the Single Ascending Dose study, a highest dose of up to 1.0 mg solution was well tolerated and only one subject reported mild tingling and numbness. In the Multiple Ascending Dose study, 0.6mg solution given in multiple doses was poorly tolerated. 3 subjects needed treatment with intravenous calcium for symptomatic low calcium levels in the blood at 0.6mg multiple doses. In the current study, the solution and tablet formulations will be tested to determine whether the rate and extent to which the solution and tablet are available in the body is equal at the same dose level. Up to twenty volunteers are planned to take part in this single site research study. They will receive the four treatments below (one in each treatment period): ?½ LEO 27847 oral solution 0.10 mg (fasted state) ?½ LEO 27847 single tablet 0.01 mg (fasted state) ?½ LEO 27847 single tablet 0.10 mg (fasted state) ?½ LEO 27847 single tablet 0.10 mg (fed state) The order in which subjects will receive the treatments will be determined randomly (by chance, like flipping a coin). In three treatment periods subjects will receive the treatment after an overnight fast of at least 10 hours and for one treatment period subjects will receive treatment 30 minutes after starting a high fat breakfast. Therefore, during the study, all subjects will receive a total of 4 doses of the study drug.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/7

• Date of REC Opinion

  27 May 2010

• REC opinion

  Further Information Favourable Opinion