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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Post Menopausal Women

Intervention / Treatment
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* Drug: ONO-5334
* Drug: ONO-5334


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E1<br>ONO-5334 | Drug: ONO-5334<br>* 150 mg for 5 days administered in the morning or in the evening<br>|
| Experimental: E2<br>ONO-5334 | Drug: ONO-5334<br>* 150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Compare pharmacodynamic effect (i.e. urine CTX) of morning versus evening multiple dosing of ONO-5334 |  | end of treatment (5 days) | 
| Part 2: Compare the effects of food on the pharmacodynamics (i.e., AUC, Cmax) of a single dose of ONO-5334 |  | end of day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |