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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01384188

Enrollment

Registered

2011-06-28

Start date

2011-06-30

Completion date

2012-12-31

Last updated

2013-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Post Menopausal Women

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.

Interventions

DRUGONO-5334

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026