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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863590
Recruitment Status : Completed
First Posted : March 18, 2009
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: odanacatib Drug: Comparator: odanacatib (Panel B) Drug: Comparator: odanacatib (Panel C) Drug: Comparator: odanacatib (Panel D) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Single Oral Rising-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK0822 in Healthy Volunteers
Study Start Date : June 2004
Actual Primary Completion Date : February 2005
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Experimental: A
Panel A
Drug: odanacatib
[Intervention Name: odanacatib (Panel A)] Panel A: Odanacatib tablets will be administered to male subjects in rising single doses of 2, 10, 50, 200, or 400 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.

Experimental: B
Panel B
Drug: Comparator: odanacatib (Panel B)
Panel B: Odanacatib tablets will be administered to male subjects in rising single doses of 5, 25 (fasting), 100, 25 (fed), or 600 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.

Experimental: C
Panel C
Drug: Comparator: odanacatib (Panel C)
Panel C: Odanacatib tablets will be administered to female subjects in rising single doses of 50 or 100 mg over 2 treatment periods. Half of the subjects will receive placebo to odanacatib in one of the 2 treatment periods. There will be at least 7 days between each treatment period.

Experimental: D
Panel D
Drug: Comparator: odanacatib (Panel D)
Panel D: Odanacatib tablets or placebo to odancatib will be administered to male subjects in rising single doses of 100, 200, or 300 mg following a high-fat breakfast over 3 treatment periods. Three of twelve subjects will receive placebo to odanacatib in all 3 treatment periods. There will be at least 10 days between each treatment period.




Primary Outcome Measures :
  1. safety and tolerability based on assessment of clinical and laboratory adverse experiences [ Time Frame: Part I: 12 Weeks, Part II: 13 Weeks ]

Secondary Outcome Measures :
  1. Plasma concentration of MK0822 [ Time Frame: Up to 336 hours postdose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is in good health
  • Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger
  • Female subject is postmenopausal
  • Subject is within 20% of ideal body weight
  • Subject is a nonsmoker

Exclusion Criteria:

  • Subject has multiple or severe allergies to food or medications
  • Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates
  • Subject has any infections, including HIV
  • Subject consumes excessive amounts of caffeine or alcohol
  • Subject has donated blood or taken another investigational drug in the last month
  • Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863590


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00863590    
Other Study ID Numbers: 0822-001
2009_562
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases