Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-5172 (MK-5172-013)
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 11/8/2014 |
Start Date: | July 2011 |
End Date: | August 2014 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
An Open-label, 3-Part, Multiple Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-5172
This study will compare the pharmacokinetics (PK) of MK-5172 when administered to
participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria
of the Child-Pugh's scale) with the PK of MK-5172 when administered to healthy participants.
participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria
of the Child-Pugh's scale) with the PK of MK-5172 when administered to healthy participants.
Inclusion Criteria:
- If female, must be of non-childbearing potential or willing to use at least 2
acceptable methods of contraception from enrollment to 2 weeks after the last dose of
study drug
- No clinically significant abnormality on electrocardiogram
Hepatic Insufficiency Participants Only:
- Other than hepatic insufficiency with features of cirrhosis, is otherwise in good
health based on medical history, physical examination, vital signs, and laboratory
safety tests
- Chronic (>6 months), stable (no acute episodes of illness within the previous 2
months due to deterioration in hepatic function) hepatic insufficiency with features
of cirrhosis due to any etiology
- Score on the Child-Pugh scale must range from 5 to 6 (mild hepatic insufficiency) to
from 7 to 9 (moderate hepatic insufficiency) to from 10 to 15 (severe hepatic
insufficiency)
Matched Healthy Participants Only:
- In good health based on medical history, physical examination, vital signs, and
laboratory safety tests
Exclusion Criteria:
- History of any illness that might confound the results of the study or poses an
additional risk to the participant
- History of clinically significant endocrine, gastrointestinal (other than related to
their hepatic impairment), cardiovascular, hematological, immunological, renal,
respiratory, or genitourinary abnormalities or diseases
- Pregnancy
- Estimated creatinine clearance of ≤60 mL/min
- History of stroke, chronic seizures, or major neurological disorder
- History of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or
myeloproliferative disease, regardless of the time since treatment
- Unable to refrain from or anticipates the use of any medication, including
prescription and non-prescription drugs or herbal remedies (such as St. John's Wort,
green tea, gingko, coenzyme Q, ginseng, echinacea, etc.) or nutritional supplements
(e.g., garlic supplements), beginning approximately 2 weeks (or 5 half-lives) prior
to administration of the initial dose of study drug, throughout the study, until the
poststudy visit
- Participated in another investigational study within 4 weeks
- History of significant multiple and/or severe allergies or has had an anaphylactic
reaction or significant intolerability to prescription or non-prescription drugs or
food
Hepatic Insufficiency Participants Only:
- Has a history of hepatitis C infection by serology, regardless of most recent viral load
status.
Matched Healthy Participants Only:
- History of any chronic and/or active hepatic disease including elevations of serum
transaminases, hepatitis, biliary tract disease, or a history of any significant
gastrointestinal surgery.
- History of hepatitis C. Participants with a history of self-limited hepatitis A with
complete resolution documented at least 6 months prior to entry will be eligible for
inclusion
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