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Completed

NCT Number: NCT01384188

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

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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Key information

Conditions

Healthy Post Menopausal Women

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Guildford Clinical Site, Guildford, Surrey, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-5334

Drug

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

Primary outcomes

  1. 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)

  2. 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

  1. 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)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jun 28, 2011
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.