Safety and Tolerability of Odanacatib (0822-059)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-08

Study Completion Date

2010-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00770159

Osteoporosis

COMPLETED PHASE1

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

NCT00769418

Osteoporosis

COMPLETED PHASE1

A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)

NCT00863525

Osteoporosis

COMPLETED PHASE1

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

NCT00863590

Osteoporosis

COMPLETED PHASE1

Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)

NCT00729183

Osteoporosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Panel A - Odanacatib

Panel A - Healthy male subjects receiving Odanacatib

Group Type EXPERIMENTAL

Odanacatib

Intervention Type DRUG

Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks

Panel A - Placebo

Panel A - Healthy male subjects receiving placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Oral Placebo tablet administered once weekly for 4 consecutive weeks

Panel B - Odanacatib

Panel B - Healthy female subjects receiving Odanacatib

Group Type EXPERIMENTAL

Odanacatib

Intervention Type DRUG

Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks

Panel B - Placebo

Panel B - Healthy female subjects receiving placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Oral Placebo tablet administered once weekly for 4 consecutive weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Odanacatib

Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks

Intervention Type DRUG

Comparator: Placebo

Oral Placebo tablet administered once weekly for 4 consecutive weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK0822

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes