A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers

A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Single Oral Rising-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK0822 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00863590

Enrollment

Registered

2009-03-18

Start date

2004-06-30

Completion date

2008-08-31

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 assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.

Interventions

DRUGodanacatib

\[Intervention Name: odanacatib (Panel A)\] Panel A: Odanacatib tablets will be administered to male subjects in rising single doses of 2, 10, 50, 200, or 400 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.

DRUGComparator: odanacatib (Panel B)

Panel B: Odanacatib tablets will be administered to male subjects in rising single doses of 5, 25 (fasting), 100, 25 (fed), or 600 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.

DRUGComparator: odanacatib (Panel C)

Panel C: Odanacatib tablets will be administered to female subjects in rising single doses of 50 or 100 mg over 2 treatment periods. Half of the subjects will receive placebo to odanacatib in one of the 2 treatment periods. There will be at least 7 days between each treatment period.

DRUGComparator: odanacatib (Panel D)

Panel D: Odanacatib tablets or placebo to odancatib will be administered to male subjects in rising single doses of 100, 200, or 300 mg following a high-fat breakfast over 3 treatment periods. Three of twelve subjects will receive placebo to odanacatib in all 3 treatment periods. There will be at least 10 days between each treatment period.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject is in good health * Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger * Female subject is postmenopausal * Subject is within 20% of ideal body weight * Subject is a nonsmoker

Exclusion criteria

* Subject has multiple or severe allergies to food or medications * Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates * Subject has any infections, including HIV * Subject consumes excessive amounts of caffeine or alcohol * Subject has donated blood or taken another investigational drug in the last month * Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug

Design outcomes

Primary

Measure	Time frame
safety and tolerability based on assessment of clinical and laboratory adverse experiences	Part I: 12 Weeks, Part II: 13 Weeks

Secondary

Measure	Time frame
Plasma concentration of MK0822	Up to 336 hours postdose

Outcome results

None listed

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