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Completed

NCT Number: NCT00863590

A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers

This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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 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

Treatment and study plan

odanacatib

Drug

[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.

Comparator: odanacatib (Panel B)

Drug

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.

Comparator: odanacatib (Panel C)

Drug

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.

Comparator: odanacatib (Panel D)

Drug

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.

Primary outcomes

  1. safety and tolerability based on assessment of clinical and laboratory adverse experiences

    Time frame: Part I: 12 Weeks, Part II: 13 Weeks

Secondary outcomes

  1. Plasma concentration of MK0822

    Time frame: Up to 336 hours postdose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2008
First posted
Mar 18, 2009
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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