Diurnal and food effects on the PK/PD profile of ONO-5334

• Research type

  Research Study

• Full title

  A two-part, crossover study to investigate the effects of morning versus evening dosing and food interaction on the pharmacodynamics and pharmacokinetics of single and multiple doses of ONO-5334 in healthy post menopausal women

• IRAS ID

  80115

• Contact name

  Aldona Greenwood

• Sponsor organisation

  ONO Pharmaceutical Co Ltd

• Eudract number

  2010-018282-36

• ISRCTN Number

  xx

• Research summary

  ONO-5334 is a drug that's currently under clinical development by Ono Pharmaceutical Co., Ltd. (ONO) as a therapeutic agent for bone metabolic diseases including osteoporosis.Osteoporosis is a disease of bones that leads to an increased risk of broken bones. These fractures/breaks mainly affect the wrist, hip and lower back. Osteoporosis is most common in women after the menopause. Currently available treatments for osteoporosis have significant limitations. Hence there is a need to develop new drugs for treating osteoporosis. ONO-5334 is a drug that may be useful in the treatment of osteoporosis. This drug inhibits an enzyme which is involved in bone resorption, and thereby this drug strengthens bones.The main purpose of this research study is to evaluate the effect on the body of dosing ONO-5334 in the morning and comparing it to the effects of dosing the same drug in the evening. In Part 2, food and fasting will be investigated to see whether these two conditions affect what the body does to the ONO-5334 and also what ONO-5334 does to the body. We will also assess the safety and tolerability of ONO-5334 during both parts of this study. 28 healthy postmenopausal women will participate in this study: 16 subjects in Part 1 and 12 subjects in Part 2. This study will be approximately 25 weeks long (from screening start to final follow up) in total. ONO-5334 has been given to 444 healthy volunteers and patients with osteoporosis in previous trials.ONO-5334 is being developed by Ono Pharmaceuticals Co., Ltd. and this study is being conducted at Quintiles Drug Research Unit at Guy??s Hospital and the Surrey Clinical Research Centre at the University of Surrey.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/0649

• Date of REC Opinion

  17 Jun 2011

• REC opinion

  Further Information Favourable Opinion