Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)
NCT ID: NCT01813513
Last Updated: 2016-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2013-01-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: IDX719 then IDX719/Simeprevir
Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.
IDX719
50 mg tablet for oral administration
Simeprevir
150 mg capsule for oral administration
Group B: Simeprevir then IDX719/Simeprevir
Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.
IDX719
50 mg tablet for oral administration
Simeprevir
150 mg capsule for oral administration
Group C: IDX719
Healthy participants take IDX719 150 mg QD on Days 1-14.
IDX719
50 mg tablet for oral administration
Group D: IDX719/Simeprevir
Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK.
IDX719
50 mg tablet for oral administration
Simeprevir
150 mg capsule for oral administration
Group E: High-Fat then Low-Fat PK
Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout).
IDX719
50 mg tablet for oral administration
Group F: Low-Fat then High-Fat PK
Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout).
IDX719
50 mg tablet for oral administration
Interventions
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IDX719
50 mg tablet for oral administration
Simeprevir
150 mg capsule for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Is pregnant or breastfeeding
* Has previously received either IDX719 or simeprevir
* Has participated in another clinical drug study within 30 days of Screening
18 Years
65 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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IDX-06A-004
Identifier Type: OTHER
Identifier Source: secondary_id
1894-004
Identifier Type: -
Identifier Source: org_study_id
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