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Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)

NCT00769418 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2015-08-19

No results posted yet for this study

Summary

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).

Conditions

Interventions

DRUG

odanacatib

Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only. Panel A: odanacatib tablets 2.5 mg qd for 14 days. Panel B: odanacatib tablets 5 mg qd for 14 days. Panel C: odanacatib tablets 10 mg qd for 14 days. Panel D: odanacatib tablets 25 mg qd for 14 days. Panel E: odanacatib tablets 0.5 mg qd for 21 days. Panel F: odanacatib tablets 2.5 mg qd for 21 days. Panel G: odanacatib tablets 10 mg qd for 21 days.

DRUG

Comparator: Placebo

Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only. Panel A: placebo to odanacatib tablets 2.5 mg qd for 14 days. Panel B: placebo to odanacatib tablets 5 mg qd for 14 days. Panel C: placebo to odanacatib tablets 10 mg qd for 14 days. Panel D: placebo to odanacatib tablets 25 mg qd for 14 days. Panel E: placebo to odanacatib tablets 0.5 mg qd for 21 days. Panel F: placebo to odanacatib tablets 2.5 mg qd for 21 days. Panel G: placebo to odanacatib tablets 10 mg qd for 21 days.

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
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2004-12-31
Completion
2006-09-30

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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 NCT00769418 on ClinicalTrials.gov