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

January 17, 2013 updated by: Ono Pharmaceutical Co. Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 1YR
        • London Clinical site
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XP
        • Guildford Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E1
ONO-5334
Drug: ONO-5334
150 mg for 5 days administered in the morning or in the evening
Drug: ONO-5334
150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal.
Experimental: E2
ONO-5334
Drug: ONO-5334
150 mg for 5 days administered in the morning or in the evening
Drug: ONO-5334
150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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
end of day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Ono Pharma UK LTD, Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • ONO-5334POE010
  • 2010-018282-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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