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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00769418
First received: October 6, 2008
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: odanacatib
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Safety and tolerability of multiple oral doses of MK0822 [ Time Frame: After 14 days of treatment for men and 21 days for women ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK profile of MK0822 [ Time Frame: predose and at selected time intervals postdose ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: September 2004
Study Completion Date: September 2006
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
odanacatib (MK0822)
Drug: odanacatib

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.

Other Name: MK0822
Placebo Comparator: 2
placebo to odanacatib (MK0822)
Drug: Comparator: 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.


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769418

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00769418     History of Changes
Other Study ID Numbers: 0822-002, MK0822-002, 2008_558
Study First Received: October 6, 2008
Last Updated: May 9, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 01, 2014