Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067 AM1)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01512667
First received: January 13, 2012
Last updated: September 11, 2012
Last verified: September 2012
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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:
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 |
| 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 May 22, 2013