Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)
NCT01907724 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2016-01-26
Summary
The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.
Conditions
- Hepatitis C, Chronic
Interventions
- DRUG
-
IDX719
IDX719 will be supplied as a 50 mg tablet for oral administration.
- DRUG
-
Simeprevir
Simeprevir will be supplied as 75 mg capsules for oral administration.
- DRUG
-
TMC647055
TMC647055 will be supplied as 150 mg capsules for oral administration.
- DRUG
-
RTV
RTV will be supplied as 80 mg/mL solution for oral administration.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2013-08-31
- Completion
- 2013-08-31
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