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Safety and Tolerability of Odanacatib (0822-059)

Merck Sharp & Dohme (MSD) logo

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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