Hepatitis C Virus (HCV) genotype-1 Infection MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: JNJ-38733214-AAA - capsule, hard (G007) - 150mg
Product Code: TMC435
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: simeprevir
CAS Number: 923604-59-5
Current Sponsor code: TMC
Sponsors
Janssen R&D Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, 12-lead electrocardiogram and vital signs, performed at screening, have a body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to screening. - Women must be postmenopausal for at least 2 years and/or surgically sterile or not heterosexually active for duration of the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - All participants with known allergies, hypersensitivity or intolerance to TMC435 or any of the excipients. - Use of concomitant medication, including over the counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen. - Any condition that, in the opinion of the investigator, would compromise the study or well-being of the participant or prevent the subject from meeting or performing study requirements. - History or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in investigator's opinion would compromise participant's safety and/or compliance with the trial procedures. - Participation in an investigational drug trial with TMC435. - Infected with HIV or Hepatitic A, B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the rate and extent of absorption of TMC435 following administration of a single dose of 2 different liquid formulations to that following administration of a single dose of the Phase III 150 mg capsule, after a highfat breakfast in healthy adult subjects. • To compare the rate and extent of absorption of TMC435 following administration of a single dose of 2 different liquid formulations in the fed (high-fat) and fasted state in healthy adult subjects. • To compare the rate and extent of absorption of TMC435 following administration of a single dose of 2 different capsule concept formulations to that following administration of a single dose of the Phase III 150 mg capsule, after a high-fat breakfast in healthy adult subjects.;Secondary Objective: • To evaluate the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy adult subjects. • To assess for the acceptability of the taste of both liquid formulations (oral solution and suspension).;Primary end point(s): Rate and extent of absorption of TMC435;Timepoint(s) of evaluation of this end point: Measured on Day 1 until Day 4 per treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Safety and tolerability 2 - Acceptability of taste;Timepoint(s) of evaluation of this end point: 1 - 18 days 2 - Day 1 of treatment B and E | — |
Countries
United Kingdom
Contacts
Public ContactJanssen Biologics BV
Janssen-Cilag International NV- Clinical Registry Group
Outcome results
None listed