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

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ClinicalTrials.gov Identifier: NCT01512667
Recruitment Status : Completed
First Posted : January 19, 2012
Results First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with impaired renal function is similar to that in matched healthy participants following a single 50 mg oral dose.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Drug: MK-0822 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Renal Insufficiency
Actual Study Start Date : January 17, 2012
Actual Primary Completion Date : August 22, 2012
Actual Study Completion Date : August 22, 2012

Arm Intervention/treatment
Experimental: Severe Renal Insufficiency Group
Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
Drug: MK-0822
A single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.
Other Name: odanacatib

Experimental: Healthy Matched Control Group
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Drug: MK-0822
A single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.
Other Name: odanacatib




Primary Outcome Measures :
  1. Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose [ Time Frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose ]
    For healthy and severe renal 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.


Secondary Outcome Measures :
  1. Maximum Concentration (Cmax) of MK-0822 After Single Dose [ Time Frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose ]
    For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.

  2. Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose [ Time Frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose ]
    For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.

  3. Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose [ Time Frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose ]
    For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512667


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01512667     History of Changes
Other Study ID Numbers: 0822-067
First Posted: January 19, 2012    Key Record Dates
Results First Posted: February 26, 2018
Last Update Posted: February 26, 2018
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases