Status:
COMPLETED
Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatic Insufficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal l...
Eligibility Criteria
Inclusion
- Not currently pregnant, nursing or planning to be pregnant through-out the course of the study; agree to use specified contraception per protocol requirement
- Body Mass Index (BMI) of ≤ 39 kg/m\^2 (not obese)
- Judged to be in good health (for healthy participant population)
- Non-smoker for the past 6-months; social smokers (smoke less than 10 cigarettes within the past 3 months; or per discretion of the study Investigator, quit smoking within the past 3 months.
- Diagnosed with chronic (more than 6 months), stable (no acute episodes of illness within the previous 2 months) hepatic insufficiency (liver dysfunction) with features of cirrhosis due to any cause (for the moderate hepatic insufficiency participant population)
- Possess the ability to understand the study, grant voluntary informed consent and willingly comply with all study requirements
Exclusion
- Does not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, or a history of a clinically significant psychiatric disorder
- Has been diagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results
- Compromised renal (kidney) function, significant organ system disease(s) or cancer(s)
- Unable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs or herbal remedies
- Meets the requirements of the study in regard to current medication profile including: prescribed medications, caffeine, alcohol, over-the-counter drugs, herbals and nutritional products; with expected non-use of recreational (illicit) drugs associated with misuse, abuse and/or addiction
- Had surgery, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product
- History of multiple and/or severe allergies, or has had a life-threatening reaction or inability to tolerate prescription or non-prescription drugs or food
Key Trial Info
Start Date :
February 23 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01512693
Start Date
February 23 2012
End Date
April 24 2012
Last Update
August 29 2018
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