Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
Primary Purpose
Chronic Hepatitis C
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IDX21459
Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C virus, HCV
Eligibility Criteria
Inclusion Criteria:
All subjects
- 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:
All subjects
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Arm Description
Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days
HCV subjects genotype 1, IDX21459 capsules, once for 1 day
HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days
Outcomes
Primary Outcome Measures
Safety and tolerability assessment
Proportion of subjects experiencing adverse events.
Secondary Outcome Measures
Pharmacokinetic
Plasma and urine concentrations of IDX21459 and its metabolite/s.
Full Information
NCT ID
NCT02112942
First Posted
April 10, 2014
Last Updated
January 25, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02112942
Brief Title
Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
Official Title
A Phase I Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Early termination of IDX21459 was due to integration of Merck's HCV antiviral pipeline has resulted in revisions of the clinical development plan.
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Hepatitis C virus, HCV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days
Arm Title
Group B
Arm Type
Experimental
Arm Description
HCV subjects genotype 1, IDX21459 capsules, once for 1 day
Arm Title
Group C
Arm Type
Experimental
Arm Description
HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days
Intervention Type
Drug
Intervention Name(s)
IDX21459
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability assessment
Description
Proportion of subjects experiencing adverse events.
Time Frame
up to 35 days
Secondary Outcome Measure Information:
Title
Pharmacokinetic
Description
Plasma and urine concentrations of IDX21459 and its metabolite/s.
Time Frame
Up to 120 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All subjects
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:
All subjects
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.
12. IPD Sharing Statement
Learn more about this trial
Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
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