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

COMPLETEDPHASE1

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

A Double-Blind, Placebo-Controlled, Once-Weekly, Multiple-Dose Study to Investigate the Safety, Tolerability, Plasma Concentration Profile and Effects on Biochemical Markers of Bone Resorption of MK0822 in Healthy Postmenopausal Female Subjects

NCT00770159•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Subject is less than or equal to 75 years of age
•Subject is a postmenopausal female
•Subject is within 30% of ideal body weight
•Subject is judged to be in good health
•Subject is a nonsmoker
•Subject is willing to avoid excessive alcohol consumption for the duration of the study
•Subject is willing to avoid strenuous physical activity for the duration of the study
•Subject agrees to refrain from consuming grapefruit or grapefruit juice for the duration of the study

Exclusion Criteria

•Subject has a history of multiple/severe allergies to foods or drugs
•Subject has had surgery within 12 weeks of starting study or has given blood within 4 weeks of starting study
•Subject has a history of major GI abnormalities/ulcers, or genitourinary, cardiovascular, hepatic, pulmonary, psychiatric, endocrine, or metabolic diseases
•Subject has a history of bone disease or treatment with bisphosphonates
•Subject has an infection/condition that would suppress the immune system, including HIV
•Subject has a history of chronic/active hepatic (liver) disease, including Hepatitis B and C
•Subject regularly uses illegal drugs
•Subject consumes more than 3 alcoholic beverages per day
•Subject consumes more than 4 cups of brewed coffee (or equivalent caffeinated beverages) per day
•Subject requires use of any prescription or non-prescription medications during the study
+1 more criteria

Key Dates

Start Date

November 1, 2004

Primary Completion Date

June 1, 2005

Completion Date

November 1, 2005

Last Updated

February 5, 2016

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

odanacatib

DRUG

Comparator: placebo to MK0822

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

NCT07281586

Osteoporosis

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RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project

Automated Bone Age Estimation From Noncontrast Abdominal CT Using Deep Learning

Effect of Mechanical Loading and Bone Loss on Motor Neuron Activity-H-Reflex Relationship

Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device