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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00769418
First received: October 6, 2008
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanatcatib (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
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: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00769418     History of Changes
Other Study ID Numbers: 2008_558, MK0822-002
Study First Received: October 6, 2008
Last Updated: September 23, 2009
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 April 23, 2014