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

Ono Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Healthy Post Menopausal Women

Treatments

Drug: ONO-5334

Study type

Interventional

Funder types

Industry

Identifiers

NCT01384188

2010-018282-36 (EudraCT Number)

ONO-5334POE010

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

Female

Ages

55 to 75 years old

Volunteers

Accepts Healthy Volunteers

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