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

NCT ID: NCT01512693

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-23
• Study Completion Date: 2012-04-24

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 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.

Conditions

Hepatic Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate Hepatic Insufficiency Group

Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.

Group Type: EXPERIMENTAL

MK-0822

Intervention Type: DRUG

A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.

Healthy Matched Control Group

Single-dose administration of odanacatib 50 mg to healthy matched control participants.

Group Type: EXPERIMENTAL

MK-0822

Intervention Type: DRUG

A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.

Interventions

MK-0822

A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.

Intervention Type: DRUG

Other Intervention Names

odanacatib

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

0822-070

Identifier Type: -

Identifier Source: org_study_id