LH-2109 first in human study in Caucasian and Japanese volunteers

• Research type

  Research Study

• Full title

  A double-blind, randomised, placebo-controlled, first in human study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of oral KLH-2109 and the effect of food in Caucasian and Japanese healthy female post- and pre-menopausal subjects after single and multiple ascending oral doses

• IRAS ID

  50254

• Contact name

  Ulrike Lorch

• Sponsor organisation

  Kissei Pharmaceutical Co., LTD.

• Eudract number

  2010-019088-13

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to determine the single-dose and multiple-dose safety and pharmacokinetic profile of KLH-2109 in healthy female volunteers. The study will also assess the suppressive effects of KLH-2109 on certain female hormones. The study drug has never been given to humans before and as such this is a first in human clinical trial. Endometriosis is a highly common disease where cells like the ones in the lining of the womb are found growing elsewhere in the body, most commonly on the ovaries. Symptoms include painful, heavy or irregular monthly periods and pelvic pain. Gonadotropin-releasing hormone (GnRH) is a peptide which binds to and activates the GnRH receptor resulting in the release of certain female hormones such as LH and FSH. Current treatment involves GnRH agonists which down regulate LH and FSH levels following an initial increase. However, they are associated with unwanted side effects because of the way they work. GnRH antagonists have recently been developed which provide immediate reduction of LH and FSH levels. KLH-2109 is a new drug which is being developed and is expected to work by reducing the levels of LH, FSH and oestradiol without the associated side effects seen with current treatment. The study will be split into two parts: single ascending dose (SAD) in healthy post- and pre-menopausal Caucasian females receiving KLH-2109 and placebo; multiple ascending doses (MAD) in healthy pre-menopausal Caucasian and Japanese females receiving KLH-2109 and placebo for 8 days. KLH-2109 will be given to post- and pre-menopausal female volunteers by mouth as tablet. The SAD part will involve 42 healthy Caucasian post-menopausal females aged 50 to 64 years inclusive and 7 healthy Caucasian pre-menopausal females aged 20 to 40 years inclusive. The MAD part will involve 48 healthy Caucasian and Japanese pre-menopausal females aged 20 to 40 years inclusive. Twenty-four of these volunteers will be Japanese. The study will be conducted at one site in the UK only.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/4

• Date of REC Opinion

  27 Apr 2010

• REC opinion

  Favourable Opinion