Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)
A Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IDX184 After Oral Administration in Healthy Subjects
2 other identifiers
interventional
48
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2008
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedApril 23, 2015
April 1, 2015
3 months
August 5, 2008
April 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of participants experiencing serious adverse events (SAEs)
Up to Day 6
Percentage of participants experiencing AEs
Up to Day 6
Percentage of participants experiencing dose-limiting toxicity (DLTs)
Up to Day 6
Percentage of participants experiencing grade 1-4 laboratory abnormalities
Up to Day 6
Study Arms (7)
IDX184 5 mg
EXPERIMENTALHealthy participants will be administered a single 5 mg dose of IDX184.
IDX184 10 mg
EXPERIMENTALHealthy participants will be administered a single 10 mg dose of IDX184.
IDX184 25 mg
EXPERIMENTALHealthy participants will be administered a single 25 mg dose of IDX184.
IDX184 50 mg
EXPERIMENTALHealthy participants will be administered a single 50 mg dose of IDX184.
IDX184 75 mg
EXPERIMENTALHealthy participants will be administered a single 75 mg dose of IDX184.
IDX184 100 mg
EXPERIMENTALHealthy participants will be administered a single 100 mg dose of IDX184.
Placebo
PLACEBO COMPARATORHealthy participants will be administered placebo matching IDX184.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participant is pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 21060109RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 8, 2008
Study Start
July 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
April 23, 2015
Record last verified: 2015-04