Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
NCT ID: NCT02112942
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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TERMINATED
PHASE1
48 participants
INTERVENTIONAL
2014-03-31
2014-06-30
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
QUADRUPLE
Study Groups
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Group A
Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days
IDX21459
Matching Placebo
Group B
HCV subjects genotype 1, IDX21459 capsules, once for 1 day
IDX21459
Group C
HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days
IDX21459
Matching Placebo
Interventions
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IDX21459
Matching Placebo
Eligibility Criteria
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Inclusion Criteria
* Subjects are in good general health.
* Subjects have provided written informed consent form.
* All subjects of childbearing potential must have agreed 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 the study drug. HCV Subjects
* Documented clinical history compatible with chronic hepatitis C without cirrhosis.
* Treatment-naïve
* HCV Genotype 1
Exclusion Criteria
* Pregnant or breastfeeding
* Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
* Decompensated liver disease
* Other clinically significant medical conditions or laboratory abnormalities.
18 Years
65 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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IDX-04C-001
Identifier Type: -
Identifier Source: secondary_id
7822-001
Identifier Type: -
Identifier Source: org_study_id
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