Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01512667
First received: January 13, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Renal Insufficiency
Drug: 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: A Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Renal 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: 0 hour to 336 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum Plasma Concentration (C (max)) After Single Dose MK-0822 [ Time Frame: 0 hour to 336 hours post-dose ] [ Designated as safety issue: No ]
  • Time to Maximum Plasma Concentration (T (max)) After Single Dose MK-0822 [ Time Frame: 0 hour to 336 hours post-dose ] [ Designated as safety issue: No ]
  • Apparent Terminal Half-Life (t (½)) After Single Dose MK-0822 [ Time Frame: 0 hour to 336 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Severe Renal Insufficiency Group Drug: MK-0822
1 single, oral dose (50 milligram [mg] tablet) of MK-0822 will be administered on Day 1.
Other Name: odanacatib
Experimental: Healthy Matched Control Group Drug: MK-0822
1 single, oral dose (50 milligram [mg] tablet) of MK-0822 will be administered on Day 1.
Other Name: odanacatib

  Eligibility

Ages Eligible for Study:   18 Years to 79 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; 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.
  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: NCT01512667     History of Changes
Other Study ID Numbers: 0822-067
Study First Received: January 13, 2012
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 20, 2014