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

Phase 1/2 Completed 25 enrolled Ono Pharmaceutical Co., Ltd.

RandomizedCrossoverSingle-blindTreatment

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.

Timeline

Start: 2011-06
Primary completion: 2011-12
Completion: 2012-12

Publications

Eastell R, Dijk DJ, Small M, Greenwood A, Sharpe J, Yamada H, Yuba M, Tanimoto M, Deacon S. Morning vs evening dosing of the cathepsin K inhibitor ONO-5334: effects on bone resorption in postmenopausal women in a randomized, phase 1 trial. Osteoporos Int. 2016 Jan;27(1):309-18. doi: 10.1007/s00198-015-3342-4. Epub 2015 Oct 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ONO-5334	Unknown	150 mg	—

Indications

No indication recorded.