A Phase 1 interventional study of JTK-853 and Dose 2 JTK-853 in Hepatitis C Virus Infection, Response to Therapy of, sponsored by Akros Pharma Inc.. Completed at 1 site in Puerto Rico. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-11-21.
Sponsored by Akros Pharma Inc. · Phase 1, Interventional, and Treatment
The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 29 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Akros Pharma Inc. is the lead sponsor of 25 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: JTK-853
Drug: Dose 2 JTK-853
Drug: Dose 3 JTK-853
Drug: Dose 4 JTK-853
Drug: Placebo
Tablets, twice a day for 3 days
Tablets, twice a day for 3 days
Tablets, three times a day for 3 days
Tablets, twice a day for 3 days
Tablets, twice a day or three times a day for 3 days
Number of subjects with adverse events
Time frame: 1 week
Maximum concentration (Cmax) of JTK-853 and metabolite M2
Time frame: 1 week
Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2
Time frame: 1 week
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2
Time frame: 1 week
Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2
Time frame: 1 week
Viral load change from baseline to end of treatment
Time frame: 48 weeks
Genotypic resistance assessment and viral load change from baseline over time
Time frame: 48 weeks
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Akros Pharma Inc.