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

Ono Pharmaceutical Co., Ltd.25 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healthy Post Menopausal Women

Interventions

ONO-5334DRUG

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

ONO-5334DRUG

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

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Guildford Clinical Site

Guildford, Surrey, United Kingdom

London Clinical Site

London, United Kingdom

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

Safety and tolerability of single or multiple dose of ONO-5334 in healthy post menopausal women

Time frame: up to the day after the last dose (Part 1: 5 day multiple doses; Part 2: single dose)

Data from ClinicalTrials.gov

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