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Completed

NCT Number: NCT00770159

A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)

This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

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 less than or equal to 75 years of age
  • Subject is a postmenopausal female
  • Subject is within 30% of ideal body weight
  • Subject is judged to be in good health
  • Subject is a nonsmoker
  • Subject is willing to avoid excessive alcohol consumption for the duration of the study
  • Subject is willing to avoid strenuous physical activity for the duration of the study
  • Subject agrees to refrain from consuming grapefruit or grapefruit juice for the duration of the study

Exclusion criteria

  • Subject has a history of multiple/severe allergies to foods or drugs
  • Subject has had surgery within 12 weeks of starting study or has given blood within 4 weeks of starting study
  • Subject has a history of major GI abnormalities/ulcers, or genitourinary, cardiovascular, hepatic, pulmonary, psychiatric, endocrine, or metabolic diseases
  • Subject has a history of bone disease or treatment with bisphosphonates
  • Subject has an infection/condition that would suppress the immune system, including HIV
  • Subject has a history of chronic/active hepatic (liver) disease, including Hepatitis B and C
  • Subject regularly uses illegal drugs
  • Subject consumes more than 3 alcoholic beverages per day
  • Subject consumes more than 4 cups of brewed coffee (or equivalent caffeinated beverages) per day
  • Subject requires use of any prescription or non-prescription medications during the study
  • Part I only: subject has received treatment with any of the following: any estrogen preparation, anabolic steroids, calcitonin, or progestins within 6 months of study start; thyroid hormone if not on a stable dose; fluoride treatment greater than 1mg/day for more than 2 weeks; Glucocorticoid treatment; Vitamin A greater than 10,000 U/day, vitamin D greater than 2000 U/day, anticonvulsants; selective estrogen receptor modulators within 6 months of study start; parathyroid hormone within 2 years of study start; or bisphosphonates.

Treatment and study plan

odanacatib

Drug

Panel A: MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: MK0822 tablets 100 mg once weekly for 6 weeks.

Comparator: placebo to MK0822

Drug

Panel A: placebo to MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: placebo to MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: placebo to MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: placebo to MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: placebo to MK0822 tablets 100 mg once weekly for 6 weeks.

Primary outcomes

  1. Number of Participants With One or More Adverse Events

    Time frame: Up to 7 weeks

  2. Number of Participants Who Discontinued Study Drug Due to Adverse Events

    Time frame: Up to 6 weeks

Secondary outcomes

  1. Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3

    Time frame: Up to 24 hours postdose, Week 1 and Week 3

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled, Once-Weekly, Multiple-Dose Study to Investigate the Safety, Tolerability, Plasma Concentration Profile and Effects on Biochemical Markers of Bone Resorption of MK0822 in Healthy Postmenopausal Female Subjects

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 9, 2008
Registry last updated
Feb 5, 2016

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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