A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers
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
2 other identifiers
interventional
24
0 countries
N/A
Brief Summary
This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2004
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedAugust 19, 2015
August 1, 2015
8 months
March 16, 2009
August 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
safety and tolerability based on assessment of clinical and laboratory adverse experiences
Part I: 12 Weeks, Part II: 13 Weeks
Secondary Outcomes (1)
Plasma concentration of MK0822
Up to 336 hours postdose
Study Arms (4)
A
EXPERIMENTALPanel A
B
EXPERIMENTALPanel B
C
EXPERIMENTALPanel C
D
EXPERIMENTALPanel D
Interventions
\[Intervention Name: odanacatib (Panel A)\] 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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Stoch SA, Zajic S, Stone JA, Miller DL, van Bortel L, Lasseter KC, Pramanik B, Cilissen C, Liu Q, Liu L, Scott BB, Panebianco D, Ding Y, Gottesdiener K, Wagner JA. Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers. Br J Clin Pharmacol. 2013 May;75(5):1240-54. doi: 10.1111/j.1365-2125.2012.04471.x.
PMID: 23013236RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
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
March 16, 2009
First Posted
March 18, 2009
Study Start
June 1, 2004
Primary Completion
February 1, 2005
Study Completion
August 1, 2008
Last Updated
August 19, 2015
Record last verified: 2015-08