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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
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 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 mg (4 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.
Unnamed facility
Kaohsiung City, Taiwan
Unnamed facility
Niaosung, Kaohsiung, Taiwan
Unnamed facility
Taichung, Taiwan
Unnamed facility
Tainan, Taiwan
Unnamed facility
Taipei, Taiwan
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.
Number of participants with HCV RNA levels below the limit of detection
Time frame: Up to 4 weeks after the last dose of study medication.
Mean plasma concentrations of JNJ-47910382
Time frame: Up to Day 9 of each treatment period.
Maximum observed plasma concentration of JNJ-47910382
Time frame: Up to Day 9 of each treatment period.
Minimum observed plasma concentration of JNJ-47910382
Time frame: Up to Day 9 of each treatment period
Time to reach the maximum plasma concentration of JNJ-47910382
Time frame: Up to Day 9 of each treatment period.
Area under the plasma concentration-time curve from time 0 to 24 hours of JNJ-47910382
Time frame: Up to Day 9 of each treatment period.
Average steady-state plasma concentration of JNJ-47910382
Time frame: Up to Day 9 of each treatment period.
Terminal elimination half life of JNJ-47910382
Time frame: Up to Day 9 of each treatment period.
The number of participants affected by an adverse event
Time frame: Up to 30 days after the last dose of study medication
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Matching Placebo administered once daily as monotherapy for 5 days.