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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||June 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
150 mg for 5 days administered in the morning or in the evening
150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal.
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.
|Guildford Clinical Site|
|Guildford, Surrey, United Kingdom, GU2 7XP|
|London Clinical Site|
|London, United Kingdom, SE1 1YR|
|Study Director:||Ono Pharma UK LTD||Ono Pharmaceutical Co. Ltd|