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
Overview
- Phase
- Phase 1
- Intervention
- ONO-5334
- Conditions
- Healthy Post Menopausal Women
- Sponsor
- Ono Pharmaceutical Co. Ltd
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Part 2: Compare the effects of food on the pharmacodynamics (i.e., AUC, Cmax) of a single dose of ONO-5334
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
E1
ONO-5334
Intervention: ONO-5334
E2
ONO-5334
Intervention: ONO-5334
Outcomes
Primary Outcomes
Part 2: Compare the effects of food on the pharmacodynamics (i.e., AUC, Cmax) of a single dose of ONO-5334
Time Frame: end of day 1
Part 1: Compare pharmacodynamic effect (i.e. urine CTX) of morning versus evening multiple dosing of ONO-5334
Time Frame: end of treatment (5 days)
Secondary Outcomes
- Safety and tolerability of single or multiple dose of ONO-5334 in healthy post menopausal women(up to the day after the last dose (Part 1: 5 day multiple doses; Part 2: single dose))