hepatitis C / liver disease
Conditions
Interventions
None listed
Sponsors
TIBOTEC PHARMACEUTICALS In Nederland vertegenwoordigd door Janssen-Cilag B.V. afdeling GCO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -male or female aged between 18-55 year -females should be amenorrheal for at least 3 years, or post-hystorectomy or post-tubal ligation -nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day -normal weight at screening (BMI 18-30 kg/m2) -healthy based on the assessments performed at screening
Exclusion criteria
Exclusion criteria: -subjects with a history of any illness that, in the opinion of the investigator or the subject*s general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject -current use of prescription medication -Regular treatment with over-the-counter medications. Subjects should stop over-the-counter medications on the date of the Screening Visit but no less than 7 days prior to the first administration of study medication -consumption of herbal medication or dietary supplements and grapefruit and grapfruit juice, apple juice, orange juice within 14 days before first administration of studymedication -consumption of more than 2 units alcoholic beverages per dag er 14 per week -consumption of more an avarage of more than 5 servings of coffee or other caffeinated beverages per day -a history of drug or alcohol abuse or addiction, or who test positive for alcohol or drugs such as cannabis, cocaine, amphetamines, benzodiazepines, or opiates during the screening period -participation in a clinical study involving administration of an investigational drug within 3 months -donation of any blood or having had a significant loss of blood within 3 months -positive test for any of the following infectious disease tests: hepatitis A infection (confirmed by hepatitis A antibody IgM), hepatitis B antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus 1 antibody (HIV1Ab), or human immunodeficiency virus 2 antibody (HIV2Ab) -male subjects with female partners that are pregnant, or planning to become pregnant during the study or within 90 days of the last dose of study medication -having participated previously in a trial with telaprevir (VX-950)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine the effect of co-administration of telepravir, given as 2 tablets of 375 mg every 8 hours and DRV/rtv or fAPV/rtv on the amount of telaprevir and DRV/rtv or fAPV/rtv in the body. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to determine the effect of telaprevir and DRV/rtv or fAPV/rtv on the amount of telaprevir and DRV/rtv and fAPV/rtv in the body when telaprevir is taken as two tablets of 375 mg every 12 hours instead of the regimen of two tablets every 8 hours. Additionally, the study wants to investigate the short term safety and tolerability of the concomitant use of telaprevir and DRV/rtv, as well as telaprevir and fAPV/rtv in healthy subjects. | — |
Countries
Netherlands
Outcome results
None listed