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Safety and Tolerability of Odanacatib (0822-059)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01068262
First received: February 11, 2010
Last updated: March 30, 2017
Last verified: March 2017
  Purpose
This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Odanacatib (MK0822) in Healthy Male and Postmenopausal Female Subjects

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

Primary Outcome Measures:
  • 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 ]
    uNTx/Cr is a biomarker of bone resorption. Urine samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4). Fold change from baseline in time weighted average (TWA) of uNTx/Cr on log scale was analyzed via a linear mixed effect model. All analyses were carried out on the log-fold scale and final results were reported on the original percent scale in WAI after back transformation. The conversion used was weighted average inhibition (WAI) = (1-exp [mean])*100, where the mean was the least squares (LS) mean of log-transformed ratio (TWA/baseline) from the above model.


Secondary Outcome Measures:
  • 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) ]
    Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state AUC0-168 hr of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Characterization of AUC0-168hr after administration of the final, Qw dose of Odanacatib 50 mg at steady state is reflective of the clinical dosing interval.

  • 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) ]
    Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Cmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.

  • Concentration of Odanacatib at 168 Hours (C168hr) in Healthy Male and Postmenopausal Female Participants at Week 4 [ Time Frame: Week 4 (168 hours postdose) ]
    Blood samples were obtained at 168 hours postdose on Day 22 (Week 4) to determine the similarity of steady-state C168hr (trough concentrations) of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.

  • 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) ]
    Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Tmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.

  • 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) ]
    Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of the apparent t1/2 of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Harmonic mean, jack-knife standard deviation reported for apparent terminal t1/2.

  • Number of Participants With At Least One Adverse Event (AE) in the Baseline, Treatment, or Post-Treatment Periods [ Time Frame: Up to Day 58 ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE. The study determined if the number of AEs experienced by participants receiving Odanacatib 50 mg Qw for 4 consecutive weeks was sufficiently low to permit continued clinical investigation. In addition to AEs during the treatment period and post-treatment follow-up period, AEs may have occurred prior to treatment in screened participants as a result of urine and blood sampling at Baseline.

  • Number of Participants Who Discontinued Study Treatment Due to an AE [ Time Frame: Up to Week 4 ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE. The study determined if the number of participants who discontinued treatment with Odanacatib 50 mg Qw for 4 consecutive weeks due to AEs was sufficiently low to permit continued clinical investigation.


Enrollment: 44
Actual Study Start Date: December 8, 2009
Study Completion Date: May 2, 2010
Primary Completion Date: April 26, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A - Odanacatib
Panel A - Healthy male subjects receiving Odanacatib
Drug: Odanacatib
Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks
Other Name: MK0822
Placebo Comparator: Panel A - Placebo
Panel A - Healthy male subjects receiving placebo
Drug: Comparator: Placebo
Oral Placebo tablet administered once weekly for 4 consecutive weeks
Experimental: Panel B - Odanacatib
Panel B - Healthy female subjects receiving Odanacatib
Drug: Odanacatib
Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks
Other Name: MK0822
Placebo Comparator: Panel B - Placebo
Panel B - Healthy female subjects receiving placebo
Drug: Comparator: Placebo
Oral Placebo tablet administered once weekly for 4 consecutive weeks

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male subject between the ages of 50 and 75 years; post menopausal female subjects between the ages of 45 and 75 years
  • Subject is in good general health
  • Subject has no evidence of metabolic bone disorder other than osteopenia or osteoporosis
  • Subject is a non-smoker

Exclusion Criteria:

  • Subject works night shift and is unable to avoid nightshift work during the study
  • Subject has had major surgery, donated blood or participated in another investigational study with in the past 4 weeks
  • Subject has a history of stroke, chronic seizures, or major neurological disease
  • Subject has a history of cancer
  • Subject consumes excessive amounts of alcohol or caffeine
  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: NCT01068262

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: NCT01068262     History of Changes
Other Study ID Numbers: 0822-059
2010_508 ( Other Identifier: Merck )
MK-0822-059
Study First Received: February 11, 2010
Results First Received: February 6, 2017
Last Updated: March 30, 2017

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

ClinicalTrials.gov processed this record on August 18, 2017