Safety and Tolerability of Odanacatib (0822-059)

• Status: Completed
• Trial end date: 2010-05-02
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• male subject between the ages of 50 and 75 years; post menopausal female subjects between the ages of 45 and 75 years

• Subject is in good general health

• Subject has no evidence of metabolic bone disorder other than osteopenia or osteoporosis

• Subject is a non-smoker

Exclusion Criteria:

• Subject works night shift and is unable to avoid nightshift work during the study

• Subject has had major surgery, donated blood or participated in another investigational study with in the past 4 weeks

• Subject has a history of stroke, chronic seizures, or major neurological disease

• Subject has a history of cancer

• Subject consumes excessive amounts of alcohol or caffeine