Safety and Tolerability of Odanacatib (0822-059)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Drug: Comparator: Placebo; Drug: Odanacatib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068262

0822-059

2010_508 (Other Identifier)

MK-0822-059

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 4 patient groups, including a placebo group

Panel A - Odanacatib

Experimental group

Description:

Panel A - Healthy male subjects receiving Odanacatib

Treatment:

Drug: Odanacatib

Panel A - Placebo

Placebo Comparator group

Description:

Panel A - Healthy male subjects receiving placebo

Treatment:

Drug: Comparator: Placebo

Panel B - Odanacatib

Experimental group

Description:

Panel B - Healthy female subjects receiving Odanacatib

Treatment:

Drug: Odanacatib

Panel B - Placebo

Placebo Comparator group

Description:

Panel B - Healthy female subjects receiving placebo

Treatment:

Drug: Comparator: Placebo