pharmacokinetic assessment of single-dose odanacatib (mk-0822) in subjects with severe renal insufficiency (mk-0822-067)

Conditions: Renal Insufficiency

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 group. the primary hypothesis is that plasma auc0-∞ of odanacatib in participants with impaired renal function is similar to that in matched healthy participants following a single 50 mg oral dose.


Eligibility criteria:
inclusion criteria: * 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 criteria: * 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.