A Study to Investigate the Effects of Food and Morning Versus Evening on Single and Multiple Doses of ONO-5334 in Healthy Post Menopausal Women

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

The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal women.

This study consists of 2 parts. Part 1; The study will investigate the effects of morning versus evening dosing on the pharmacodynamics of multiple doses of 150 mg of ONO-5334 in healthy post menopausal women. The study design will be single-blind and 16 subjects will be enrolled. Part 2; The study will investigate the effects of food on the pharmacokinetics of a single dose of 150mg of ONO-5334 in healthy post menopausal women. 12 subjects will be enrolled.

Inclusion Criteria:

• Healthy caucasian women aged between 55 to 75 years inclusive
• Subjects weighing at least 50 kg with mass index between 19 to 30 kg/m2 inclusive
• Subjects who have been amenorrhoeic for at least 5 years.
• Subjects who are confirmed at Screening Visit to have oestradiol and follicle stimulating hormone (FSH) levels consistent with menopause

Exclusion Criteria:

• Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
• Subjects who have a clinically relevant history of insomnia or sleep disorders