Safety and Tolerability of Odanacatib (0822-059)

NCT01068262 | Completed Phase 1 Results

• 3 other identifiers: 0822-0592010_508MK-0822-059
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Baseline to Week 4

Secondary Outcomes (7)

• Area Under the Curve of Plasma Concentration-time From 0 to 168 Hours (AUC0-168hr) of Odanacatib at Week 4

  Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)

• Overall Maximum Concentration (Cmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4

  Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)

• Concentration of Odanacatib at 168 Hours (C168hr) in Healthy Male and Postmenopausal Female Participants at Week 4

  Week 4 (168 hours postdose)

• Overall Time to Maximum Concentration (Tmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4

  Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)

• Apparent Terminal Half-Life (t1/2) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4

  Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)

Study Arms (4)

Panel A - Odanacatib

EXPERIMENTAL

Panel A - Healthy male subjects receiving Odanacatib

Drug: Odanacatib

Panel A - Placebo

PLACEBO COMPARATOR

Panel A - Healthy male subjects receiving placebo

Drug: Comparator: Placebo

Panel B - Odanacatib

EXPERIMENTAL

Panel B - Healthy female subjects receiving Odanacatib

Drug: Odanacatib

Panel B - Placebo

PLACEBO COMPARATOR

Panel B - Healthy female subjects receiving placebo

Drug: Comparator: Placebo

Interventions

Odanacatib DRUG

Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks

Also known as: MK0822

Panel A - Odanacatib; Panel B - Odanacatib

Comparator: Placebo DRUG

Oral Placebo tablet administered once weekly for 4 consecutive weeks

Panel A - Placebo; Panel B - Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Anderson MS, Gendrano IN, Liu C, Jeffers S, Mahon C, Mehta A, Mostoller K, Zajic S, Morris D, Lee J, Stoch SA. Odanacatib, a selective cathepsin K inhibitor, demonstrates comparable pharmacodynamics and pharmacokinetics in older men and postmenopausal women. J Clin Endocrinol Metab. 2014 Feb;99(2):552-60. doi: 10.1210/jc.2013-1688. Epub 2013 Nov 25.

  PMID: 24276460 RESULT

MeSH Terms

Conditions

Osteoporosis

Interventions

odanacatib

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Vice President, Late Stage Development Group Leader
• Organization: Merck Sharp and Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 12, 2010
• Study Start: December 8, 2009
• Primary Completion: April 26, 2010
• Study Completion: May 2, 2010
• Last Updated: August 28, 2018
• Results First Posted: June 16, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share