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Safety and Tolerability of Odanacatib (0822-059)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01068262
First Posted: February 12, 2010
Last Update Posted: June 16, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: February 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: Odanacatib
Drug: Comparator: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Healthy Males: Odanacatib (Panel A) Healthy male participants randomized to Odanacatib 50 mg tablet administered once weekly (Qw) for 4 consecutive weeks
Healthy Males: Placebo (Panel A) Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
Healthy Postmenopausal Females: Odanacatib (Panel B) Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
Healthy Postmenopausal Females: Placebo (Panel B) Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks

Participant Flow:   Overall Study
    Healthy Males: Odanacatib (Panel A)   Healthy Males: Placebo (Panel A)   Healthy Postmenopausal Females: Odanacatib (Panel B)   Healthy Postmenopausal Females: Placebo (Panel B)
STARTED   23   9   10   2 
COMPLETED   20   8   9   2 
NOT COMPLETED   3   1   1   0 
Adverse Event                2                0                1                0 
Protocol Violation                1                0                0                0 
Withdrawal by Subject                0                1                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Healthy Males: Odanacatib (Panel A) Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
Healthy Males: Placebo (Panel A) Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
Healthy Postmenopausal Females: Odanacatib (Panel B) Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
Healthy Postmenopausal Females: Placebo (Panel B) Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
Total Total of all reporting groups

Baseline Measures
   Healthy Males: Odanacatib (Panel A)   Healthy Males: Placebo (Panel A)   Healthy Postmenopausal Females: Odanacatib (Panel B)   Healthy Postmenopausal Females: Placebo (Panel B)   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   9   10   2   44 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 58.35  (6.11)   56.44  (6.60)   57.50  (7.59)   65.00  (14.14)   58.07  (6.84) 
[1] Baseline age in each of the four study treatment groups and the total study population
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      0   0.0%      0   0.0%      10 100.0%      2 100.0%      12  27.3% 
Male      23 100.0%      9 100.0%      0   0.0%      0   0.0%      32  72.7% 


  Outcome Measures
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1.  Primary:   Weighted Average Inhibition (WAI) of Urine Aminoterminal Crosslinked Telopeptide of Type I Collagen (u-NTx/Cr) After Administration of Odanacatib 50 mg or Placebo Qw for 4 Weeks in Healthy Males and Postmenopausal Females   [ Time Frame: Baseline to Week 4 ]

2.  Secondary:   Area Under the Curve of Plasma Concentration-time From 0 to 168 Hours (AUC0-168hr) of Odanacatib at Week 4   [ Time Frame: Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) ]

3.  Secondary:   Overall Maximum Concentration (Cmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4   [ Time Frame: Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) ]

4.  Secondary:   Concentration of Odanacatib at 168 Hours (C168hr) in Healthy Male and Postmenopausal Female Participants at Week 4   [ Time Frame: Week 4 (168 hours postdose) ]

5.  Secondary:   Overall Time to Maximum Concentration (Tmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4   [ Time Frame: Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) ]

6.  Secondary:   Apparent Terminal Half-Life (t1/2) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4   [ Time Frame: Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) ]

7.  Secondary:   Number of Participants With At Least One Adverse Event (AE) in the Baseline, Treatment, or Post-Treatment Periods   [ Time Frame: Up to Day 58 ]

8.  Secondary:   Number of Participants Who Discontinued Study Treatment Due to an AE   [ Time Frame: Up to Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp and Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01068262     History of Changes
Other Study ID Numbers: 0822-059
2010_508 ( Other Identifier: Merck )
MK-0822-059
First Submitted: February 11, 2010
First Posted: February 12, 2010
Results First Submitted: February 6, 2017
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017