Phase 1
N=17
Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)
Hepatic Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT01512693 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose — 28.84; 33.79 μM*hr
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MK-0822 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2012
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 |
28.84; 33.79 | — |
| SECONDARY Maximum Concentration (Cmax) of MK-0822 After Single Dose |
199.41; 279.59 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose |
4.00; 24.00 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose |
91.5; 70.5 | — |
Summary
This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose.
Eligibility Criteria
Inclusion Criteria
- Not currently pregnant, nursing or planning to be pregnant through-out the course of the study; agree to use specified contraception per protocol requirement
- Body Mass Index (BMI) of ≤ 39 kg/m^2 (not obese)
- Judged to be in good health (for healthy participant population)
- Non-smoker for the past 6-months; social smokers (smoke less than 10 cigarettes within the past 3 months; or per discretion of the study Investigator, quit smoking within the past 3 months.
- Diagnosed with chronic (more than 6 months), stable (no acute episodes of illness within the previous 2 months) hepatic insufficiency (liver dysfunction) with features of cirrhosis due to any cause (for the moderate hepatic insufficiency participant population)
- Possess the ability to understand the study, grant voluntary informed consent and willingly comply with all study requirements
Exclusion Criteria
- Does not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, or a history of a clinically significant psychiatric disorder
- Has been diagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results
- Compromised renal (kidney) function, significant organ system disease(s) or cancer(s)
- Unable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs or herbal remedies
- 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
- Had surgery, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product
- History of multiple and/or severe allergies, or has had a life-threatening reaction or inability to tolerate prescription or non-prescription drugs or food
Data sourced from ClinicalTrials.gov (NCT01512693). 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.