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
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 April 17, 2014