Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-3281 in Healthy and Hepatitis C Infected Male Participants (MK-3281-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This study will examine the safety, tolerability and plasma pharmacokinetics of multiple doses of MK-3281 in healthy male participants in Part I, and in Hepatitis C Virus (HCV)-infected male participa...
Eligibility Criteria
Inclusion
- Participant is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
- Participant has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
- Participants with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
- Participant has a clinical diagnosis of chronic HCV infection (for Part II only).
Exclusion
- Participant has a history of stroke, chronic seizures, or major neurological disorder
- Participant has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- Participant has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
- Participant has positive Hepatitis B surface antigen (or other evidence of active Hepatitis B infection) at the prescreening (study) visit
- For Healthy Panel (Part I), participant has evidence of chronic Hepatitis C virus infection at the prescreening (study) visit
- Participant has a history of documented Human Immunodeficiency Virus (HIV) infection
Key Trial Info
Start Date :
February 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00635804
Start Date
February 19 2008
End Date
December 22 2009
Last Update
September 5 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.