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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01512693
First received: January 13, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hepatic Insufficiency
Drug: Single Dose MK-0822
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Hepatic Insufficiency

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Area Under the Curve from Zero (0) Hours to Infinity (AUC (0-∞)) After Single Dose MK-0822 [ Time Frame: From time of administration of MK-0822, defined as 0 hours on Study Day 1, to 336 hours (postdose on Post Study Day 15) (Interim postdose blood draws are scheduled at 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, and 240 hours). ] [ Designated as safety issue: No ]
    AUC (0∞) is defined as: area under the plasma (serum) concentration-time curve from zero to infinity. For this study, pre-determined blood-draw time points will range from 0 hours, at time of administration of MK-0822 on Study Day 1, to 336 hours on Post-Study Day 15.


Secondary Outcome Measures:
  • Maximum Plasma Concentration (C (max)) After Single Dose MK-0822 [ Time Frame: From time of administration of MK-0822, defined as 0 hours on Study Day 1, to 336 hours (postdose on Post Study Day 15) (Interim postdose blood draws are scheduled at 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, and 240 hours). ] [ Designated as safety issue: No ]
    C (max) is defined as: the peak plasma (serum) concentration of a therapeutic drug. For this study, pre-determined blood-draw time points will range from 0 hours, at time of administration of MK-0822 on Study Day 1, to 336 hours on Post-Study Day 15.

  • Time to Maximum Plasma Concentration (T (max)) After Single Dose MK-0822 [ Time Frame: From time of administration of MK-0822, defined as 0 hours on Study Day 1, to 336 hours (postdose on Post Study Day 15) (Interim postdose blood draws are scheduled at 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, and 240 hours). ] [ Designated as safety issue: No ]
    T (max) is defined as the time it takes the administered drug to reach maximum (peak) plasma (serum) concentration. For this study, pre-determined blood-draw time points will range from 0 hours, at time of administration of MK-0822 on Study Day 1, to 336 hours on Post-Study Day 15.

  • Apparent Terminal Half-Life (t(½)) After Single Dose MK-0822 [ Time Frame: From time of administration of MK-0822, defined as 0 hours on Study Day 1, to 336 hours (postdose on Post Study Day 15) (Interim postdose blood draws are scheduled at 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, and 240 hours). ] [ Designated as safety issue: No ]
    Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For this study, pre-determined blood-draw time points will range from 0 hours, at time of administration of MK-0822 on Study Day 1, to 336 hours on Post-Study Day 15.


Enrollment: 16
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0822-Participants /Moderate Hepatic Insufficiency
Eight (8) participants with moderate hepatic insufficiency will be screened to ensure that they meet study criteria prior to receiving one 50 milligram (mg) dose of MK-0822. After administration of the MK-0822, the participants will undergo timed and sequential blood draws through post-study, Day 15. The resulting assays will provide pharmacokinetic measurements and will aid in the assessment of overall exposure associated with MK-0822-070.
Drug: Single Dose MK-0822
A one-time, single-dose (50 mg tablet) administered orally on Day 1
Other Name: odanacatib
Experimental: MK-0822/Healthy Volunteers
Eight (8) healthy participants will be screened to ensure that they meet study criteria prior to receiving one 50 milligram (mg) dose of MK-0822. After administration of the MK-0822, the participants will undergo timed and sequential blood draws through Day 15. The resulting assays will provide pharmacokinetic measurements and will aid in the assessment of overall exposure associated with MK-0822-070.
Drug: Single Dose MK-0822
A one-time, single-dose (50 mg tablet) administered orally on Day 1
Other Name: odanacatib

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01512693     History of Changes
Other Study ID Numbers: 0822-070
Study First Received: January 13, 2012
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014