Phase 1
Completed N=25
Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)
Source: ClinicalTrials.gov NCT01512667 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose — 51.47; 32.12 μM*hr
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose |
51.47; 32.12 | — |
| SECONDARY Maximum Concentration (Cmax) of MK-0822 After Single Dose |
359.85; 246.09 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose |
18.01; 4.02 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose |
73.9; 80.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01512667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.