Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Hepatic Insufficiency

Treatments

Drug: MK-0822

Study type

Interventional

Funder types

Industry

Identifiers

NCT01512693

0822-070

Details and patient eligibility

About

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 liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose.

Enrollment

17 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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