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

NCT00770159 | Completed Phase 1

• 3 other identifiers: 0822-005MK0822-0052008_559
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With One or More Adverse Events

  Up to 7 weeks

• Number of Participants Who Discontinued Study Drug Due to Adverse Events

  Up to 6 weeks

Secondary Outcomes (1)

• Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3

  Up to 24 hours postdose, Week 1 and Week 3

Study Arms (2)

1

EXPERIMENTAL

MK0822

Drug: odanacatib

2

PLACEBO COMPARATOR

Placebo to MK0822

Drug: Comparator: placebo to MK0822

Interventions

odanacatib DRUG

Panel A: MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: MK0822 tablets 100 mg once weekly for 6 weeks.

1

Comparator: placebo to MK0822 DRUG

Panel A: placebo to MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: placebo to MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: placebo to MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: placebo to MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: placebo to MK0822 tablets 100 mg once weekly for 6 weeks.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Part I only: subject has received treatment with any of the following: any estrogen preparation, anabolic steroids, calcitonin, or progestins within 6 months of study start; thyroid hormone if not on a stable dose; fluoride treatment greater than 1mg/day for more than 2 weeks; Glucocorticoid treatment; Vitamin A greater than 10,000 U/day, vitamin D greater than 2000 U/day, anticonvulsants; selective estrogen receptor modulators within 6 months of study start; parathyroid hormone within 2 years of study start; or bisphosphonates.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Stoch SA, Zajic S, Stone J, Miller DL, Van Dyck K, Gutierrez MJ, De Decker M, Liu L, Liu Q, Scott BB, Panebianco D, Jin B, Duong LT, Gottesdiener K, Wagner JA. Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double-blind, randomized, placebo-controlled phase I studies. Clin Pharmacol Ther. 2009 Aug;86(2):175-82. doi: 10.1038/clpt.2009.60. Epub 2009 May 6.

  PMID: 19421185 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Interventions

odanacatib

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: November 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: November 1, 2005
• Last Updated: February 5, 2016

Record last verified: 2016-01