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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT01384188
First received: June 27, 2011
Last updated: January 17, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Healthy Post Menopausal Women
Drug: ONO-5334
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E1
ONO-5334
Drug: ONO-5334
150 mg for 5 days administered in the morning or in the evening
Experimental: E2
ONO-5334
Drug: ONO-5334
150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384188

Locations
United Kingdom
Guildford Clinical Site
Guildford, Surrey, United Kingdom, GU2 7XP
London Clinical Site
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Ono Pharma UK LTD Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01384188     History of Changes
Other Study ID Numbers: ONO-5334POE010, 2010-018282-36
Study First Received: June 27, 2011
Last Updated: January 17, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on April 22, 2014