Hepatitis C Virus InfectionPhase 1NCT01482611
A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382
A Phase 1 study testing JNJ-47910382 in people with Hepatitis C Virus Infection, run by Janssen R&D Ireland at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the safety, tolerability and plasma pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food) from 10 mg up to 600 mg or up to the maximum tolerated dose or up to the dose that yields a JNJ-47910382 plasma level that approaches the predefined… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- JNJ-47910382
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Apr 2012
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian subjects between 18 and 45 years of age, inclusive.
- Japanese subjects between 20 and 45 years of age, inclusive.
- MALE Japanese subjects who has resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese
- A body weight above 50 kg at screening
- Non-smoking for at least 3 months prior to screening
Who cannot join
- Female Caucasian, except if postmenopausal for at least 2 years or be surgically sterile.
- Hepatitis A, B or C infection
- Human Immunodeficiency Virus Type 1 (HIV-1) or Human Immunodeficiency Virus Type 2 (HIV-2) infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, First-in-human, Double-blind, Randomized, Placebo-controlled Trial to Examine the Safety, Tolerability and Plasma Pharmacokinetics of Increasing Single Oral Doses of JNJ-47910382 in Healthy Caucasian and Japanese Volunteers
The purpose of this study is to investigate the safety, tolerability and plasma pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food) from 10 mg up to 600 mg or up to the maximum tolerated dose or up to the dose that yields a JNJ-47910382 plasma level that approaches the predefined maximum mean exposure (whichever comes first) in healthy Caucasian and Japanese participants. The foreseen maximum dose is 600 mg. In addition, the effect of fasting (ie JNJ-47910382 is taken without food) on the plasma pharmacokinetics of JNJ-47910382 after one selected oral dose given to healthy Caucasian participants will be studied. JNJ-47910382 is a drug that is being developed to treat Hepatitis C infection and is an inhibitor of the reproduction machinery of the Hepatitis C virus (HCV). Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Read the detailed description
This is a Phase I, single-center, first-in-human, double-blind (neither the participant nor the investigator/medical staff knows whether placebo or JNJ-47910382 is given at a certain moment), randomized (treatment with placebo or JNJ-47910382 is assigned by chance), placebo-controlled trial in 18 healthy Caucasian and 16 healthy Japanese participants to investigate the safety, tolerability and plasma pharmacokinetics of single oral doses of JNJ-47910382. This trial consists of 3 Parts: 1. a single dose escalation part in healthy male and female Caucasians, 2. a single dose study investigating the effect of fasting in healthy male and female Caucasians and 3. a single dose escalation part in healthy male Japanese participants. Part 1 holds 6 sessions, each testing another dose of JNJ-47910382. Part 2 holds 1 session testing one dose and Part 3 holds 3 sessions, each testing another dose of JNJ-47910382. The doses pre-defined for the Caucasian cohort in Part 1 are 10 mg, 30 mg, 75 mg, 150 mg, 300 mg, and 600 mg, given in Session I till and including Session VI, respectively. These doses may be adjusted based on results obtained from previous sessions, but will not exceed 600 mg, the predefined maximal tolerated dose or a dose that yields a JNJ-47910382 plasma levels that approaches the predefined maximum mean exposure. The foreseen maximum dose is 600 mg.The doses for the Japanese cohort, given in Session VIII till and including Session X, respectively, and the dose for the fasting-session (Session VII) will be defined during the conduct of the study, based on the safety, tolerability and PK profiles obtained in the previously completed sessions. The Caucasian cohort is divided over 2 panels (Panel 1 and 2) of 9 participants, and to each Panel, 3 different doses are assigned, respecting a washout period of at least 10 days. The Japanese cohort is divided over 2 panels (Panel 3 and 4) of 8 participants and to Panel 3, 2 different doses are assigned, respecting a washout period of at least 10 days, and to Panel 4 only 1 dose of JNJ-47910382 is assigned. Either Panel 1 or 2 will be selected for the fasting-study Session, depending on the dose that has been selected for this fasting-study. Both, JNJ-47910382 and the placebo are liquids and will be administered in the mouth of the participants via an oral dispenser. The decision to escalate to the next dose in Part 1 and 3 will be taken with caution. After each session, the safety and tolerability (till and including 96h post dose) and the PK (till and including 24h post dose) results will be evaluated by the sponsor and principle investigator - in a blinded fashion. Only in case the previous dose is shown to be generally safe and tolerable and the maximum tolerated dose and the maximal mean plasma JNJ-47910382 levels have not been reached and the PK profile is satisfactory, the next session can start, using a selected and agreed dose. Safety evaluations between sessions include adverse events, vital signs (blood pressure and heart rate), electrocardiogram (ECG) (evaluation of the activity of the heart at certain time points), heart telemetry (continuous evaluation of the activity of the heart, for 12 hours), physical examination and clinical laboratory tests. Throughout the trial, in each session, the plasma PK profiles of JNJ-47910382 will be determined up to 96 hours after dosing. Also the amount of JNJ-47910382 recovered in the urine will be determined over 72 hours after intake of study medication in Session IV and in the Japanese Session with the same dose (either Session VIII, IX or X). A blood sample dedicated for the analysis of specific genes involved in the PK (metabolism) and transport of JNJ-47910382 will be collected from each participant, preferentially on Day-2 of one of the sessions. Also safety and tolerability of JNJ-47910382 will be determined throughout the trial. In each session a triplicate ECG is taken, vital signs are recorded, urinalysis is performed and biochemical and blood parameters are assessed on Days 1, 2 and 4. On Day3, vital signs are recorded and a triplicate ECG taken. On Day-1, a triplicate ECG is taken. Heart telemetric recordings are performed on Day-1 and Day1 for 12 hours. Physical examination occurs on Day-1 and Day5.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- JNJ-47910382, Placebo
- Keywords
- Hepatitis C Virus, JNJ-47910382, 47910382HPC1001, HCV, Hepatitis C, Hep C, Healthy participants, Japanese, Caucasians
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-47910382Drug
Type = exact number, unit = mg, number = 10, 75, 300, form = suspension, route = oral use.
JNJ-47910382Drug
Type = exact number, unit = mg, number = 30, 150, 600, form = suspension, route = oral use.
JNJ-47910382Drug
Type = exact number, unit = mg, number = To be determined, form = suspension, route = oral use.
JNJ-47910382Drug
Type = exact number, unit = mg, number = To be determined, form = suspension, route = oral use.
PlaceboDrug
Type = exact number, unit = mg, number = equivalent of 10, 75, 300, form = suspension, route = oral use.
PlaceboDrug
Type = exact number, unit = mg, number = equivalent of 30, 150, 600, form = suspension, route = oral use
PlaceboDrug
Type = exact number, unit = mg, number = equivalent dose to be determined, form = suspension, route = oral use.
PlaceboDrug
Type = exact number, unit = mg, number = equivalent dose to be determined, form = suspension, route = oral use
| Study group | Role | What they receive |
|---|---|---|
| Panel 1: Caucasian | Experimental | 10, 75 and 300 mg JNJ-47910382 or placebo Receives: Drug: JNJ-47910382; Drug: Placebo |
| Panel 2: Caucasian | Experimental | 30, 150, 600 mg JNJ-47910382 or placebo Receives: Drug: JNJ-47910382; Drug: Placebo |
| Panel 3: Japanese | Experimental | Session VIII and X: Doses of JNJ-47910382 or placebo to be determined Receives: Drug: JNJ-47910382; Drug: Placebo |
| Panel 4: Japanese | Experimental | Session IX: Dose of JNJ-47910382 or placebo to be determined Receives: Drug: JNJ-47910382; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with adverse events as a measure of safety and tolerability of JNJ-47910382 for each dose tested.
Adverse Events (AEs) with onset during the treatment phase and AEs that have worsened since baseline will be analysed.
Measured: As of Day1 till and including 30-35 days after last drug intake
PK parameters after increasing single oral doses of JNJ-47910382, from 10 mg up to the maximum tolerated dose or up to 600 mg or up to the dose that yields a plasma level that approaches the predefined maximum mean exposure of JNJ-47910382.
PK characteristics of JNJ-47910382 are determined based on plasma levels at one time point (Day3, 4 and 5), at 2 time points (Day2) and at 11 time points (Day1). Standard PK parameters such as Cmax (maximal concentration), Tmax (time point at moment maximal concentration is reached), AUClast (Area Under the Curve from time point of drug administration up to the last time point with a measurable concentration post dosing) etc. will be determined.
Measured: Measured on Day1 till and including Day5 (i.e. predose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h post dose) in each session.
Change from baseline values for clinical laboratory parameters for each dose group.
Measured: On Day1, 2 and 4 during treatment, on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).
Change from baseline values for ECG for each dose group.
Measured: On Day-1, 1, 2, 3 and 4 during treatment and on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session)..
Change from baseline values for vital signs for each dose group.
Measured: On Day1, 2, 3 and 4 during treatment and on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).
Change from baseline values for physical examination for each dose group.
Measured: On Day-1, 4, Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).
Change from baseline values for cardia telemetry for each dose group.
Measured: Day1 (12 hours post-dose)
Percentage of participants with adverse events as a measure of safety and tolerability of JNJ-47910382 for each dose tested.
AEs with onset during the treatment phase and AEs that have worsened since baseline will be analysed.
Measured: As of Day1 till and including 30-35 days after drop out (and Day of drop out can be from day of dosing in first session till 96h postdosing in last session)..
Secondary outcomes (1)
Sequencing of genes that may affect safety, tolerability or PK of JNJ-47910382.
Drug transporter genes OATP (organic anion transporting polypeptide) 1B1, OATP2B1, OATP1B3, ATP-binding cassette sub-family member ABCG2, ABCB1, multidrug resistance-associated protein MRP2 and bile salt export pump BSEP.
Measured: Per participant, once during the conduct of the study, preferentially on Day-2 of one of the sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen R&D Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen R&D Ireland Clinical Trial, Study director, Janssen R&D Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482611
- Sponsor's protocol ID
- CR018547
- Other IDs
- 47910382HPC1001, 2011-003196-11
- Status last verified
- Feb 2013
- First submitted
- 24 Oct 2011
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, First-in-human, Double-blind, Randomized, Placebo-controlled Trial to Examine the Safety, Tolerability and Plasma Pharmacokinetics of Increasing Single Oral Doses of JNJ-47910382 in Healthy Caucasian and Japanese Volunteers
- ClinicalTrials.gov ID
- NCT01482611
- Acronym / sponsor ID
- CR018547
- Conditions
- Hepatitis C Virus Infection
- Keywords
- Hepatitis C Virus, JNJ-47910382, 47910382HPC1001, HCV, Hepatitis C, Hep C, Healthy participants, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Janssen R&D IrelandIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 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 is to investigate the safety, tolerability and plasma pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food) from 10 mg up to 600 mg or up to the maximum tolerated dose or up to the dose that yields a JNJ-47910382 plasma level that approaches the predefined maximum mean exposure (whichever comes first) in healthy Caucasian and Japanese participants. The foreseen maximum dose is 600 mg. In addition, the effect of fasting (ie JNJ-47910382 is taken without food) on the plasma pharmacokinetics of JNJ-47910382 after one selected oral dose given to healthy Caucasian participants will be studied. JNJ-47910382 is a drug that is being developed to treat Hepatitis C infection and is an inhibitor of the reproduction machinery of the Hepatitis C virus (HCV). Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Detailed description
This is a Phase I, single-center, first-in-human, double-blind (neither the participant nor the investigator/medical staff knows whether placebo or JNJ-47910382 is given at a certain moment), randomized (treatment with placebo or JNJ-47910382 is assigned by chance), placebo-controlled trial in 18 healthy Caucasian and 16 healthy Japanese participants to investigate the safety, tolerability and plasma pharmacokinetics of single oral doses of JNJ-47910382. This trial consists of 3 Parts: 1. a single dose escalation part in healthy male and female Caucasians, 2. a single dose study investigating the effect of fasting in healthy male and female Caucasians and 3. a single dose escalation part in healthy male Japanese participants. Part 1 holds 6 sessions, each testing another dose of JNJ-47910382. Part 2 holds 1 session testing one dose and Part 3 holds 3 sessions, each testing another dose of JNJ-47910382. The doses pre-defined for the Caucasian cohort in Part 1 are 10 mg, 30 mg, 75 mg, 150 mg, 300 mg, and 600 mg, given in Session I till and including Session VI, respectively. These doses may be adjusted based on results obtained from previous sessions, but will not exceed 600 mg, the predefined maximal tolerated dose or a dose that yields a JNJ-47910382 plasma levels that approaches the predefined maximum mean exposure. The foreseen maximum dose is 600 mg.The doses for the Japanese cohort, given in Session VIII till and including Session X, respectively, and the dose for the fasting-session (Session VII) will be defined during the conduct of the study, based on the safety, tolerability and PK profiles obtained in the previously completed sessions. The Caucasian cohort is divided over 2 panels (Panel 1 and 2) of 9 participants, and to each Panel, 3 different doses are assigned, respecting a washout period of at least 10 days. The Japanese cohort is divided over 2 panels (Panel 3 and 4) of 8 participants and to Panel 3, 2 different doses are assigned, respecting a washout period of at least 10 days, and to Panel 4 only 1 dose of JNJ-47910382 is assigned. Either Panel 1 or 2 will be selected for the fasting-study Session, depending on the dose that has been selected for this fasting-study. Both, JNJ-47910382 and the placebo are liquids and will be administered in the mouth of the participants via an oral dispenser. The decision to escalate to the next dose in Part 1 and 3 will be taken with caution. After each session, the safety and tolerability (till and including 96h post dose) and the PK (till and including 24h post dose) results will be evaluated by the sponsor and principle investigator - in a blinded fashion. Only in case the previous dose is shown to be generally safe and tolerable and the maximum tolerated dose and the maximal mean plasma JNJ-47910382 levels have not been reached and the PK profile is satisfactory, the next session can start, using a selected and agreed dose. Safety evaluations between sessions include adverse events, vital signs (blood pressure and heart rate), electrocardiogram (ECG) (evaluation of the activity of the heart at certain time points), heart telemetry (continuous evaluation of the activity of the heart, for 12 hours), physical examination and clinical laboratory tests. Throughout the trial, in each session, the plasma PK profiles of JNJ-47910382 will be determined up to 96 hours after dosing. Also the amount of JNJ-47910382 recovered in the urine will be determined over 72 hours after intake of study medication in Session IV and in the Japanese Session with the same dose (either Session VIII, IX or X). A blood sample dedicated for the analysis of specific genes involved in the PK (metabolism) and transport of JNJ-47910382 will be collected from each participant, preferentially on Day-2 of one of the sessions. Also safety and tolerability of JNJ-47910382 will be determined throughout the trial. In each session a triplicate ECG is taken, vital signs are recorded, urinalysis is performed and biochemical and blood parameters are assessed on Days 1, 2 and 4. On Day3, vital signs are recorded and a triplicate ECG taken. On Day-1, a triplicate ECG is taken. Heart telemetric recordings are performed on Day-1 and Day1 for 12 hours. Physical examination occurs on Day-1 and Day5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Panel 1: Caucasian | Experimental | Drug: JNJ-47910382, Drug: Placebo10, 75 and 300 mg JNJ-47910382 or placebo |
| Panel 2: Caucasian | Experimental | Drug: JNJ-47910382, Drug: Placebo30, 150, 600 mg JNJ-47910382 or placebo |
| Panel 3: Japanese | Experimental | Drug: JNJ-47910382, Drug: PlaceboSession VIII and X: Doses of JNJ-47910382 or placebo to be determined |
| Panel 4: Japanese | Experimental | Drug: JNJ-47910382, Drug: PlaceboSession IX: Dose of JNJ-47910382 or placebo to be determined |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Caucasian subjects between 18 and 45 years of age, inclusive.
- Japanese subjects between 20 and 45 years of age, inclusive.
- MALE Japanese subjects who has resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese
- A body weight above 50 kg at screening
- Non-smoking for at least 3 months prior to screening
Key exclusion criteria (3 listed)
- Female Caucasian, except if postmenopausal for at least 2 years or be surgically sterile.
- Hepatitis A, B or C infection
- Human Immunodeficiency Virus Type 1 (HIV-1) or Human Immunodeficiency Virus Type 2 (HIV-2) infection
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 |
|---|---|---|
| JNJ-47910382Type = exact number, unit = mg, number = 10, 75, 300, form = suspension, route = oral use. | Drug | Panel 1: Caucasian |
| JNJ-47910382Type = exact number, unit = mg, number = 30, 150, 600, form = suspension, route = oral use. | Drug | Panel 2: Caucasian |
| JNJ-47910382Type = exact number, unit = mg, number = To be determined, form = suspension, route = oral use. | Drug | Panel 3: Japanese |
| JNJ-47910382Type = exact number, unit = mg, number = To be determined, form = suspension, route = oral use. | Drug | Panel 4: Japanese |
| PlaceboType = exact number, unit = mg, number = equivalent of 10, 75, 300, form = suspension, route = oral use. | Drug | Panel 1: Caucasian |
| PlaceboType = exact number, unit = mg, number = equivalent of 30, 150, 600, form = suspension, route = oral use | Drug | Panel 2: Caucasian |
| PlaceboType = exact number, unit = mg, number = equivalent dose to be determined, form = suspension, route = oral use. | Drug | Panel 3: Japanese |
| PlaceboType = exact number, unit = mg, number = equivalent dose to be determined, form = suspension, route = oral use | Drug | Panel 4: Japanese |
Primary outcome
Percentage of participants with adverse events as a measure of safety and tolerability of JNJ-47910382 for each dose tested.
Time frame: As of Day1 till and including 30-35 days after last drug intake
Adverse Events (AEs) with onset during the treatment phase and AEs that have worsened since baseline will be analysed.
PK parameters after increasing single oral doses of JNJ-47910382, from 10 mg up to the maximum tolerated dose or up to 600 mg or up to the dose that yields a plasma level that approaches the predefined maximum mean exposure of JNJ-47910382.
Time frame: Measured on Day1 till and including Day5 (i.e. predose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h post dose) in each session.
PK characteristics of JNJ-47910382 are determined based on plasma levels at one time point (Day3, 4 and 5), at 2 time points (Day2) and at 11 time points (Day1). Standard PK parameters such as Cmax (maximal concentration), Tmax (time point at moment maximal concentration is reached), AUClast (Area Under the Curve from time point of drug administration up to the last time point with a measurable concentration post dosing) etc. will be determined.
Change from baseline values for clinical laboratory parameters for each dose group.
Time frame: On Day1, 2 and 4 during treatment, on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).
Change from baseline values for ECG for each dose group.
Time frame: On Day-1, 1, 2, 3 and 4 during treatment and on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session)..
Change from baseline values for vital signs for each dose group.
Time frame: On Day1, 2, 3 and 4 during treatment and on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).
Change from baseline values for physical examination for each dose group.
Time frame: On Day-1, 4, Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).
Change from baseline values for cardia telemetry for each dose group.
Time frame: Day1 (12 hours post-dose)
Percentage of participants with adverse events as a measure of safety and tolerability of JNJ-47910382 for each dose tested.
Time frame: As of Day1 till and including 30-35 days after drop out (and Day of drop out can be from day of dosing in first session till 96h postdosing in last session)..
AEs with onset during the treatment phase and AEs that have worsened since baseline will be analysed.
1 secondary outcome
Sequencing of genes that may affect safety, tolerability or PK of JNJ-47910382.
Time frame: Per participant, once during the conduct of the study, preferentially on Day-2 of one of the sessions.
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 20 Feb 2013.
Related trials for Hepatitis C Virus Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Janssen R&D Ireland Clinical Trial study director
Janssen R&D Ireland
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 JNJ-47910382 in people with Hepatitis C Virus Infection, run by Janssen R&D Ireland at 1 site in Germany.
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 5 inclusion and 3 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 20 Feb 2013. 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 Germany. 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. 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?
Percentage of participants with adverse events as a measure of safety and tolerability of JNJ-47910382 for each dose tested. (time frame: As of Day1 till and including 30-35 days after last drug intake). The study lists 8 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 20 Feb 2013.