Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)
Primary Purpose
Renal Insufficiency
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK-0822
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Severe Renal Insufficiency Group
Healthy Matched Control Group
Arm Description
Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Outcomes
Primary Outcome Measures
Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose
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
Maximum Concentration (Cmax) of MK-0822 After Single Dose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.
Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.
Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2.
Full Information
NCT ID
NCT01512667
First Posted
January 13, 2012
Last Updated
July 30, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01512667
Brief Title
Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)
Official Title
A Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Renal Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 17, 2012 (Actual)
Primary Completion Date
August 22, 2012 (Actual)
Study Completion Date
August 22, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Severe Renal Insufficiency Group
Arm Type
Experimental
Arm Description
Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
Arm Title
Healthy Matched Control Group
Arm Type
Experimental
Arm Description
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Intervention Type
Drug
Intervention Name(s)
MK-0822
Other Intervention Name(s)
odanacatib
Intervention Description
A single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.
Primary Outcome Measure Information:
Title
Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose
Description
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.
Time Frame
Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
Secondary Outcome Measure Information:
Title
Maximum Concentration (Cmax) of MK-0822 After Single Dose
Description
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.
Time Frame
Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
Title
Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose
Description
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.
Time Frame
Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
Title
Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose
Description
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2.
Time Frame
Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)
We'll reach out to this number within 24 hrs