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

Phase 1

Completed

• Conditions: Healthy Post Menopausal Women
• Interventions: Drug: ONO-5334

• Registration Number: NCT01384188
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2011-12
• Status Verified: 2012-07
• Study Completion: 2012-12
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
E1	ONO-5334	ONO-5334
E2	ONO-5334	ONO-5334

Primary Outcome Measures

Name	Time	Method
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
Part 1: Compare pharmacodynamic effect (i.e. urine CTX) of morning versus evening multiple dosing of ONO-5334	end of treatment (5 days)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

London Clinical Site; 🇬🇧 London, United Kingdom

Guildford Clinical Site; 🇬🇧 Guildford, Surrey, United Kingdom