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

NCT01512693 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 0822-070
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose

  For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.

  Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

Secondary Outcomes (3)

• Maximum Concentration (Cmax) of MK-0822 After Single Dose

  Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

• Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose

  Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

• Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose

  Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

Study Arms (2)

Moderate Hepatic Insufficiency Group

EXPERIMENTAL

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

Drug: MK-0822

Healthy Matched Control Group

EXPERIMENTAL

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

Drug: MK-0822

Interventions

MK-0822 DRUG

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

Also known as: odanacatib

Healthy Matched Control Group; Moderate Hepatic Insufficiency Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

odanacatib

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 19, 2012
• Study Start: February 23, 2012
• Primary Completion: April 24, 2012
• Study Completion: April 24, 2012
• Last Updated: August 29, 2018
• Results First Posted: October 27, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share