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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Healthy Post Menopausal Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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E1

ONO-5334

Group Type EXPERIMENTAL

ONO-5334

Intervention Type DRUG

150 mg for 5 days administered in the morning or in the evening

E2

ONO-5334

Group Type EXPERIMENTAL

ONO-5334

Intervention Type DRUG

150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal.

Interventions

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ONO-5334

150 mg for 5 days administered in the morning or in the evening

Intervention Type DRUG

ONO-5334

150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal.

Intervention Type DRUG

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes