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A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)

NCT00770159 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2016-02-05

No results posted yet for this study

Summary

This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.

Conditions

Interventions

DRUG

odanacatib

Panel A: MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: MK0822 tablets 100 mg once weekly for 6 weeks.

DRUG

Comparator: placebo to MK0822

Panel A: placebo to MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: placebo to MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: placebo to MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: placebo to MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: placebo to MK0822 tablets 100 mg once weekly for 6 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-06-30
Completion
2005-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00770159 on ClinicalTrials.gov