Status:
COMPLETED
Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief Summary
This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib administered to participants with impaired renal/kidney function to those of a healthy matched control gro...
Eligibility Criteria
Inclusion
- Not currently pregnant, nursing or planning to be pregnant through-out the course of the study; individual agrees to use specified contraception per protocol requirement for duration of study. Note: All females must have a serum pregnancy test to ensure and document negative test results prior to inclusion in the study.
- Body Mass Index (BMI) of up to 39.49kg/m\^2
- Assessed to be in good health, including no clinically significant cardiac abnormalities based on results from an electrocardiogram (ECG) performed at pre-screening and/or prior to administration of study drug.
- 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.
- Agrees to adhere to all smoking and dietary restrictions associated with the study.
- Possess the ability to understand the study, grant voluntary informed consent, and willingly comply with all study requirements.
- Inclusion Criterion Specific to Participants with Renal/Kidney Insufficiency:
- Creatinine clearance of \<30 mL/min
- Inclusion Criterion Specific to Healthy Volunteers:
- Creatine clearance of ≥ 90 mL/min (for healthy volunteers)
Exclusion
- Does not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, and/or a history of a clinically significant psychiatric disorder.
- Diagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results.
- Has demonstrated or suspected stenosis (narrowing) of the renal artery, and/or has had a renal transplant and/or kidney removal.
- Has current, unstable, significant organ system disease(s) and/or cancer(s).
- Has had a surgical procedure, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product.
- Unable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs and/or herbal remedies. Exceptions may include medications prescribed for prevention of disease or preservation of a healthy life.
- Uses any medication or agent that has the potential to significantly alter renal/kidney function.
- Unable to avoid taking diuretics (within 4 hours prior to and after dosing with the investigational product) or phosphate binders containing aluminum, calcium or lanthanum salts; iron supplements or other metal cations; antacids; or multivitamins containing iron or zinc (within 8 hours prior to dosing and 4 hours after dosing with the investigational product). Note: individuals prescribed to diuretics must be on a stable dose for at least 4 weeks prior to the study's start date in order to participate.
- History of multiple and/or severe allergies, has had a life-threatening reaction to a drug or other agent, and/or inability to tolerate prescription or nonprescription drugs and/or food.
Key Trial Info
Start Date :
January 17 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01512667
Start Date
January 17 2012
End Date
August 22 2012
Last Update
August 28 2018
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