CompletedNCT00863525Updated Aug 19, 2015

A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)

A Phase 1 interventional study of odanacatib and Comparator: Placebo in Osteoporosis, sponsored by Merck Sharp & Dohme LLC. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-19.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 8
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Male

Study summary

This study will assess the safety and tolerability of single doses of odanacatib (MK0822) when administered with a light breakfast.

Conditions studied

Osteoporosis

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Osteoporosis 1,640

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 8 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

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Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Subject is male and between the ages of 18 and 45
Subject is within 25% of ideal body weight and weighs between 55 and 95 kg
Subject is in generally good health
Subject is a nonsmoker

Exclusion criteria

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 has donated blood or taken another investigational drug in the last month
Subject consumes excessive amounts of caffeine or alcohol
Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 8 participants (actual)

Study arms

Experimental
1
Odanacatib
Drug: odanacatib
Placebo comparator
2
Placebo
Drug: Comparator: Placebo

Interventions

Drugodanacatib
A single oral dose of 100 mg odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.
Also known as: MK0822
DrugComparator: Placebo
A single oral dose of Placebo to odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.

What researchers measure

Primary outcomes

Safety and tolerability of MK0822 based on clinical and laboratory adverse experiences
Time frame: Throughout the study
Effect of a low-fat meal on pharmacokinetics of MK0822
Time frame: Through 240 hours post-dose

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 23013236 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00863525
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Mar 18, 2009
Start date: Nov 2004
Primary completion: Dec 2004
Completion: Jun 2006
Last update: Aug 19, 2015

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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