Hepatitis C Virus Infection, Response to Therapy ofPhase 1NCT01473056
Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects
A Phase 1 study testing JTK-853, Dose 2 JTK-853 and Dose 3 JTK-853 in people with Hepatitis C Virus Infection, Response to Therapy of, run by Shionogi Inc. at 1 site in Puerto Rico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C Virus Infection, Response to Therapy of
- What is being tested?
- JTK-853, Dose 2 JTK-853 and Dose 3 JTK-853
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Aug 2010to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females infected with chronic hepatitis C virus (HCV) infection and genotype 1a or 1b
- Subjects with a viral load (HCV RNA level) of ≥50,000 IU/mL
- Subjects with a body mass index (BMI) of 18.0-36.0 kg/m2 (inclusive)
Who cannot join
- Subjects should not have previously received a direct acting anti-HCV agent
- Subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I,Randomized,Double-blind,Placebo-controlled,Multiple Dose Study Evaluating Safety,Tolerability,Pharmacokinetics and Antiviral Activity of JTK-853 in HCV Genotype 1 Infected Subjects,Followed by a Genotypic Resistance Monitoring Study
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.
- Being tested
- JTK-853, Dose 2 JTK-853, Dose 3 JTK-853, Dose 4 JTK-853, Placebo
- Keywords
- Hepatitis C, JTK-853
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTK-853Drug
Tablets, twice a day for 3 days
Dose 2 JTK-853Drug
Tablets, twice a day for 3 days
Dose 3 JTK-853Drug
Tablets, three times a day for 3 days
Dose 4 JTK-853Drug
Tablets, twice a day for 3 days
PlaceboDrug
Tablets, twice a day or three times a day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 JTK-853 | Experimental | Not described Receives: Drug: JTK-853 |
| Dose 2 JTK-853 | Experimental | Not described Receives: Drug: Dose 2 JTK-853 |
| Dose 3 JTK-853 | Experimental | Not described Receives: Drug: Dose 3 JTK-853 |
| Dose 4 JTK-853 | Experimental | Not described Receives: Drug: Dose 4 JTK-853 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: 1 week
Maximum concentration (Cmax) of JTK-853 and metabolite M2
Measured: 1 week
Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2
Measured: 1 week
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2
Measured: 1 week
Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2
Measured: 1 week
Viral load change from baseline to end of treatment
Measured: 48 weeks
Genotypic resistance assessment and viral load change from baseline over time
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus Infection, Response to Therapy ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shoji Hoshino, D.V.M, Study director, Shionogi Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473056
- Sponsor's protocol ID
- AK853-U-09-002
- Status last verified
- Nov 2011
- First submitted
- 9 Nov 2011
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I,Randomized,Double-blind,Placebo-controlled,Multiple Dose Study Evaluating Safety,Tolerability,Pharmacokinetics and Antiviral Activity of JTK-853 in HCV Genotype 1 Infected Subjects,Followed by a Genotypic Resistance Monitoring Study
- ClinicalTrials.gov ID
- NCT01473056
- Acronym / sponsor ID
- AK853-U-09-002
- Keywords
- Hepatitis C, JTK-853
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose 1 JTK-853 | Experimental | Drug: JTK-853 |
| Dose 2 JTK-853 | Experimental | Drug: Dose 2 JTK-853 |
| Dose 3 JTK-853 | Experimental | Drug: Dose 3 JTK-853 |
| Dose 4 JTK-853 | Experimental | Drug: Dose 4 JTK-853 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females infected with chronic hepatitis C virus (HCV) infection and genotype 1a or 1b
- Subjects with a viral load (HCV RNA level) of ≥50,000 IU/mL
- Subjects with a body mass index (BMI) of 18.0-36.0 kg/m2 (inclusive)
Key exclusion criteria (2 listed)
- Subjects should not have previously received a direct acting anti-HCV agent
- Subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JTK-853Tablets, twice a day for 3 days | Drug | Dose 1 JTK-853 |
| Dose 2 JTK-853Tablets, twice a day for 3 days | Drug | Dose 2 JTK-853 |
| Dose 3 JTK-853Tablets, three times a day for 3 days | Drug | Dose 3 JTK-853 |
| Dose 4 JTK-853Tablets, twice a day for 3 days | Drug | Dose 4 JTK-853 |
| PlaceboTablets, twice a day or three times a day for 3 days | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shoji Hoshino, D.V.M study director
Shionogi Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JTK-853, Dose 2 JTK-853 and Dose 3 JTK-853 in people with Hepatitis C Virus Infection, Response to Therapy of, run by Shionogi Inc. at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: 1 week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2011.