Completed

NCT Number: NCT00769418

Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).

Completed

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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–70 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 a male between the ages of 18 and 45 or a female less than or equal to 70 years of age
Females must be past menopause
Subject is a nonsmoker
Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling
Subject is willing to refrain from consuming grapefruit or grapefruit juice

Exclusion criteria

Subject has a history of multiple/severe allergies to drugs or food
Subject has donated blood within 4 weeks of starting the study
Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment
Subject has any infections or any condition leading to immune problems, including HIV
Subject regularly uses illegal drugs
Subject consumes more than 3 alcoholic beverages per day
Subject drinks 4 or more caffeinated beverages per day
Subject uses any prescription or nonprescription medications

Treatment and study plan

odanacatib

Drug

Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.

Panel A: odanacatib tablets 2.5 mg qd for 14 days.

Panel B: odanacatib tablets 5 mg qd for 14 days.

Panel C: odanacatib tablets 10 mg qd for 14 days.

Panel D: odanacatib tablets 25 mg qd for 14 days.

Panel E: odanacatib tablets 0.5 mg qd for 21 days.

Panel F: odanacatib tablets 2.5 mg qd for 21 days.

Panel G: odanacatib tablets 10 mg qd for 21 days.

Other names: MK0822

Comparator: placebo

Drug

Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.

Panel A: placebo to odanacatib tablets 2.5 mg qd for 14 days.

Panel B: placebo to odanacatib tablets 5 mg qd for 14 days.

Panel C: placebo to odanacatib tablets 10 mg qd for 14 days.

Panel D: placebo to odanacatib tablets 25 mg qd for 14 days.

Panel E: placebo to odanacatib tablets 0.5 mg qd for 21 days.

Panel F: placebo to odanacatib tablets 2.5 mg qd for 21 days.

Panel G: placebo to odanacatib tablets 10 mg qd for 21 days.

Primary outcomes

Safety and tolerability of multiple oral doses of MK0822

Time frame: After 14 days of treatment for men and 21 days for women

Secondary outcomes

PK profile of MK0822

Time frame: predose and at selected time intervals postdose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Multiple Oral Dose Study, to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0822 in Healthy Male and Postmenopausal Female Subjects

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2006
First posted: Oct 9, 2008
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.

Published trials that share one or more normalized conditions with this study.

Completed