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

A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Multiple Oral Dose Study, to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0822 in Healthy Male and Postmenopausal Female Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00769418

Enrollment

Registered

2008-10-09

Start date

2004-09-30

Completion date

2006-09-30

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Brief summary

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

Interventions

DRUGodanacatib

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.

DRUGComparator: 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age * Females must be past menopause * Subject is a nonsmoker * Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling * Subject is willing to refrain from consuming grapefruit or grapefruit juice

Exclusion criteria

* Subject has a history of multiple/severe allergies to drugs or food * Subject has donated blood within 4 weeks of starting the study * Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment * Subject has any infections or any condition leading to immune problems, including HIV * Subject regularly uses illegal drugs * Subject consumes more than 3 alcoholic beverages per day * Subject drinks 4 or more caffeinated beverages per day * Subject uses any prescription or nonprescription medications

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of multiple oral doses of MK0822	After 14 days of treatment for men and 21 days for women

Secondary

Measure	Time frame
PK profile of MK0822	predose and at selected time intervals postdose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026