Back to resultsSingle-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IDX184
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, healthy volunteers
Eligibility Criteria
Inclusion Criteria:
- Participants are in general good health.
- All participants of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control
Exclusion Criteria:
- Participant is pregnant or breastfeeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
IDX184 5 mg
IDX184 10 mg
IDX184 25 mg
IDX184 50 mg
IDX184 75 mg
IDX184 100 mg
Placebo
Arm Description
Healthy participants will be administered a single 5 mg dose of IDX184.
Healthy participants will be administered a single 10 mg dose of IDX184.
Healthy participants will be administered a single 25 mg dose of IDX184.
Healthy participants will be administered a single 50 mg dose of IDX184.
Healthy participants will be administered a single 75 mg dose of IDX184.
Healthy participants will be administered a single 100 mg dose of IDX184.
Healthy participants will be administered placebo matching IDX184.
Outcomes
Primary Outcome Measures
Percentage of participants experiencing serious adverse events (SAEs)
Percentage of participants experiencing AEs
Percentage of participants experiencing dose-limiting toxicity (DLTs)
Percentage of participants experiencing grade 1-4 laboratory abnormalities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00730431
Brief Title
Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)
Official Title
A Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IDX184 After Oral Administration in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (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
The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, healthy volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IDX184 5 mg
Arm Type
Experimental
Arm Description
Healthy participants will be administered a single 5 mg dose of IDX184.
Arm Title
IDX184 10 mg
Arm Type
Experimental
Arm Description
Healthy participants will be administered a single 10 mg dose of IDX184.
Arm Title
IDX184 25 mg
Arm Type
Experimental
Arm Description
Healthy participants will be administered a single 25 mg dose of IDX184.
Arm Title
IDX184 50 mg
Arm Type
Experimental
Arm Description
Healthy participants will be administered a single 50 mg dose of IDX184.
Arm Title
IDX184 75 mg
Arm Type
Experimental
Arm Description
Healthy participants will be administered a single 75 mg dose of IDX184.
Arm Title
IDX184 100 mg
Arm Type
Experimental
Arm Description
Healthy participants will be administered a single 100 mg dose of IDX184.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Healthy participants will be administered placebo matching IDX184.
Intervention Type
Drug
Intervention Name(s)
IDX184
Intervention Description
IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo supplied as size 3, white opaque capsules matching IDX184 capsules.
Primary Outcome Measure Information:
Title
Percentage of participants experiencing serious adverse events (SAEs)
Time Frame
Up to Day 6
Title
Percentage of participants experiencing AEs
Time Frame
Up to Day 6
Title
Percentage of participants experiencing dose-limiting toxicity (DLTs)
Time Frame
Up to Day 6
Title
Percentage of participants experiencing grade 1-4 laboratory abnormalities
Time Frame
Up to Day 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants are in general good health.
All participants of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control
Exclusion Criteria:
Participant is pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21060109
Citation
Zhou XJ, Pietropaolo K, Chen J, Khan S, Sullivan-Bolyai J, Mayers D. Safety and pharmacokinetics of IDX184, a liver-targeted nucleotide polymerase inhibitor of hepatitis C virus, in healthy subjects. Antimicrob Agents Chemother. 2011 Jan;55(1):76-81. doi: 10.1128/AAC.01101-10. Epub 2010 Nov 8.
Results Reference
result
Learn more about this trial
Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)
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