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:
Ono Pharmaceutical Co. Ltd
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 June 17, 2013