Osteoporosis
Conditions
Brief summary
This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.
Interventions
DRUGodanacatib
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.
DRUGComparator: placebo to MK0822
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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With One or More Adverse Events | Up to 7 weeks |
| Number of Participants Who Discontinued Study Drug Due to Adverse Events | Up to 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3 | Up to 24 hours postdose, Week 1 and Week 3 |
Outcome results
None listed