Study 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 Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
A Phase I Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
2 other identifiers
interventional
48
0 countries
N/A
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.
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 Mar 2014
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 10, 2014
CompletedFirst Posted
Study publicly available on registry
April 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJanuary 26, 2016
January 1, 2016
3 months
April 10, 2014
January 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability assessment
Proportion of subjects experiencing adverse events.
up to 35 days
Secondary Outcomes (1)
Pharmacokinetic
Up to 120 hours post dose
Study Arms (3)
Group A
EXPERIMENTALHealthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days
Group B
EXPERIMENTALHCV subjects genotype 1, IDX21459 capsules, once for 1 day
Group C
EXPERIMENTALHCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2014
First Posted
April 14, 2014
Study Start
March 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
January 26, 2016
Record last verified: 2016-01