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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Healthy Post Menopausal Women

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2011-06-28
• Last updated: 2013-01-18

Locations

2 sites across 1 country: United Kingdom