Status:
COMPLETED
Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions b...
Eligibility Criteria
Inclusion
- Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
- Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of study drug
- Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study
Exclusion
- Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
- Is pregnant or breastfeeding
- Has previously received either IDX719 or simeprevir
- Has participated in another clinical drug study within 30 days of Screening
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01813513
Start Date
January 1 2013
End Date
July 1 2013
Last Update
January 26 2016
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