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AzTrials

Chronic Hepatitis C InfectionPhase 1NCT01586325

A Study of the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of JNJ-47910382 at Different Doses and Dose Regimens in Asian Genotype-1, Chronic, HCV-Infected Patients

A Phase 1 study testing JNJ-47910382 30 mg, JNJ-47910382 90 mg and JNJ-47910382 200 mg in people with Chronic Hepatitis C Infection, run by Janssen R&D Ireland at 5 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (how a drug is absorbed and distributed in the body), and intrinsic antiviral activity of JNJ-47910382 after 5 consecutive days of administration in chronic, hepatitis C virus (HCV)-genotype-1-infected patients at different doses and… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis C Infection
What is being tested?
JNJ-47910382 30 mg, JNJ-47910382 90 mg and JNJ-47910382 200 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
5 sitesTaiwan
Study dates
25 May 2012to 21 Apr 2014
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented chronic HCV infection (diagnosis of hepatitis C >= 6 months before the screening period)
  • HCV geno- and subtype of 1a or 1b (Panel 1) or 1b (Panels 2 and 3)
  • Patient has never received pegylated interferon, ribavirin, or any other approved or investigational antiviral treatment for chronic HCV infection
  • Patient with HCV ribonucleic acid (RNA) level of >100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay)
  • A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included
  • A body weight above 50 kg
  • Normal 12-lead electrocardiogram (ECG) at screening

Who cannot join

  • Evidence of or documented liver cirrhosis
  • Evidence of decompensated liver disease
  • Evidence of any other cause of significant liver disease in addition to hepatitis C
  • History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the Investigator's opinion would compromise patient's safety and/or compliance with the study procedures
  • A positive urine drug (with exclusion of methadone or equivalent) test at study screening
  • Patient with protocol-defined laboratory abnormalities at screening
Show all 11Show fewer
  • Patient coinfected with HIV-1 or HIV-2, or hepatitis A or B virus infection, or active tuberculosis at study screening
  • Patient infected/coinfected with non-genotype 1 HCV at study screening
  • Patient with any cardiac disease at screening, or any active clinically significant disease (eg, cardiac dysfunction, cardio(myo)pathy, cardiac insufficiency), or medical history or physical examination findings during screening that, in the Investigator's opinion, would compromise the outcome of the trial
  • Patient having uncontrolled/unstable disease such as diabetes, epilepsy, a manifest psychiatric disease, or thyroid disease or disorders
  • Patient with non-stable methadone (or equivalent drug) use

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Taiwan5 sites

  • Study site

    Kaohsiung City

  • Study site

    Niaosung, Kaohsiung

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

Other trials in Taiwan

About this study

Official title: A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Trial in Asian Genotype 1 Chronic HCV-Infected Subjects to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Repeated Doses of JNJ-47910382 Given in Different Doses and Dose Regimens

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (how a drug is absorbed and distributed in the body), and intrinsic antiviral activity of JNJ-47910382 after 5 consecutive days of administration in chronic, hepatitis C virus (HCV)-genotype-1-infected patients at different doses and dose regimens.

Read the detailed description

This is a double-blind (neither physician nor patient knows the name of the assigned drug), randomized (patients are assigned by chance to treatment groups) placebo-controlled study. A placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. The study population will consist of Asian treatment-naive genotype-1, chronic HCV-infected patients. The trial will involve a screening period at a maximum of 6 weeks before baseline, a 9-day treatment period (with 5 days of actual medication intake) and a 4-week follow-up period. Patients will be divided into 3 panels of 8 patients (Panel 1) or 5 patients (Panels 2 and 3). Treatment will be initiated in each panel of patients sequentially. In each panel, patients will receive JNJ-47910382 or placebo during 5 consecutive days. JNJ-47910382, or placebo, will be administered once daily. Treatments will be taken by mouth and with standardized meals in all dosing regimens. Patient safety will be monitored.

Being tested
JNJ-47910382 30 mg, JNJ-47910382 90 mg, JNJ-47910382 200 mg, Placebo
Keywords
Chronic hepatitis C infection, Asian genotype 1 chronic hepatitis C infection, JNJ-47910382, Non-structural protein 5A (NS5A) inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-47910382 30 mgDrug

    JNJ-47910382 30 mg (0.6 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.

  • JNJ-47910382 90 mgDrug

    JNJ-47910382 90 mg (1.8 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.

  • JNJ-47910382 200 mgDrug

    JNJ-47910382 200 mg (4 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.

  • PlaceboDrug

    Matching Placebo administered once daily as monotherapy for 5 days.

Study groups in NCT01586325
Study groupRoleWhat they receive
Panel 1ExperimentalStudy participants will receive double-blind treatment with JNJ-47910382 30 mg or matching placebo. Participants in each of Panel will be treated sequentially (ie, participants in Panel 1 will be treated before participants in Panel 2, participants in Panel 2 will be treated before participants in Panel 3).
Receives: Drug: JNJ-47910382 30 mg; Drug: Placebo
Panel 2ExperimentalStudy participants will receive double-blind treatment with JNJ-47910382 90 mg or matching placebo. Participants in each of Panel will be treated sequentially.
Receives: Drug: JNJ-47910382 90 mg; Drug: Placebo
Panel 3ExperimentalStudy participants will receive double-blind treatment with JNJ-47910382 200 mg (maxiumum dose) or matching placebo. Participants in each of Panel will be treated sequentially.
Receives: Drug: JNJ-47910382 200 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HCV RNA levels over time during the 5-day treatment regimen

    Measured: Up to 4 weeks after the last dose of study medication.

  2. Number of participants with HCV RNA levels below the limit of detection

    Measured: Up to 4 weeks after the last dose of study medication.

Secondary outcomes (8)

  1. Mean plasma concentrations of JNJ-47910382

    Measured: Up to Day 9 of each treatment period.

  2. Maximum observed plasma concentration of JNJ-47910382

    Measured: Up to Day 9 of each treatment period.

  3. Minimum observed plasma concentration of JNJ-47910382

    Measured: Up to Day 9 of each treatment period

  4. Time to reach the maximum plasma concentration of JNJ-47910382

    Measured: Up to Day 9 of each treatment period.

  5. Area under the plasma concentration-time curve from time 0 to 24 hours of JNJ-47910382

    Measured: Up to Day 9 of each treatment period.

  6. Average steady-state plasma concentration of JNJ-47910382

    Measured: Up to Day 9 of each treatment period.

  7. Terminal elimination half life of JNJ-47910382

    Measured: Up to Day 9 of each treatment period.

  8. The number of participants affected by an adverse event

    Measured: Up to 30 days after the last dose of study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2012 (estimated)
  2. Study start25 May 2012
  3. Primary completion21 Apr 2014
  4. Study completion21 Apr 2014

Why it stopped: Because of many competing trials using the same mechanism of action, but being further advanced in development

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01586325
Sponsor's protocol ID
CR100718
Other IDs
47910382HPC1003
Status last verified
Mar 2019
First submitted
24 Apr 2012
Last updated
27 Mar 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-47910382 30 mg, JNJ-47910382 90 mg and JNJ-47910382 200 mg in people with Chronic Hepatitis C Infection, run by Janssen R&D Ireland at 5 sites in Taiwan.

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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Taiwan. 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 was stopped early (reason given: Because of many competing trials using the same mechanism of action, but being further advanced in development). Results are not available in the source record.

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?

Change from baseline in HCV RNA levels over time during the 5-day treatment regimen (time frame: Up to 4 weeks after the last dose of study medication.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01586325.

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 27 Mar 2019.

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