Clinical trial NCT01651767: Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382
Official title: A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Trial in Caucasian 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Hepatitis C Infection
Keywords: Chronic hepatitis C virus infection
JNJ-47910382
Pharmacokinetics
Caucasian genotype-1
Non-structural protein 5A (NS5A) inhibitor
Lead sponsor: Janssen R&D Ireland
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics (what the body does to the medication) and antiviral activity of JNJ-47910382 when administered in different dosing regimens in Caucasian genotype-1 chronic HCV-infected patients.

Detailed description: This is a Phase Ib, double-blind (neither physician nor patient knows the treatment that the patient receives), randomized (the study drug is assigned by chance), placebo-controlled study in treatment-naïve (someone who has never used drugs for HCV infection), Caucasian genotype 1 chronic HCV-infected patients. The study consists of a screening period, a 9-day treatment period (with 5 days of actual medication intake) and a 4-week follow-up period. The patients will be divided over 4 panels of 10 patients each that will be initiated sequentially. In each panel patients will receive JNJ-47910382 or placebo during 5 consecutive days. JNJ-47910382 or placebo will be administered once daily or twice daily. Within each panel, 5 patients of genotype-1a and 5 patients of genotype-1b will be enrolled. Patients will be randomly assigned to receive active treatment or placebo in such a way that 4 patients of each genotype receive active treatment and 1 subject of each genotype receives placebo. The pharmacokinetic profile of JNJ-47910382 will be assessed in each panel. HCV RNA kinetics (HCV RNA level) and HCV resistance will be studied and biomarkers at the messenger RNA (mRNA), protein and cell level will be explored. The entire study duration for each participant will be approximately four weeks.

Eligibility criteria: Inclusion Criteria:

* Chronic (diagnosis of hepatitis C more than or 6 months before the screening period) HCV infection. Geno- and subtype should be determined or confirmed at screening, and should be 1a or 1b
* Never received (Peg) IFN, RBV or any other approved or investigational antiviral treatment for chronic HCV infection
* HCV RNA level of \>100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay)
* Patients having good accessible veins

Exclusion Criteria:

* Evidence of liver cirrhosis or decompensated liver disease
* 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, or medical history or physical examination findings during screening
* Patient having uncontrolled/unstable disease such as diabetes, epilepsy, a manifest psychiatric disease, thyroid disease or disorders

Primary outcomes:
measure: Determination of pharmacokinetics of JNJ-47910382
timeFrame: Up to 9 Days
measure: Evaluation of the intrinsic antiviral activity of JNJ-47910382
timeFrame: Up to 4 weeks
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Mainz
country: Germany
city: Münster
country: Germany
city: Tübingen
country: Germany
city: Ulm
country: Germany
Study officials:
affiliation: Janssen R&D Ireland
name: Janssen R&D Ireland Clinical Trial
role: STUDY_DIRECTOR
References: