hepatitis C / liver disease
Conditions
Interventions
None listed
Sponsors
Tibotec Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Permission in writing from volunteer to participate in this trial 2. Age 18-55 years 3. In good physical and mental health 4. Normal weight length ratio (BMI 18-30 kg/m2); 5. Women should be postmenopausal for at least 2 years, or have undergone a hysterectomy, or have had a tubal ligation (without reversal operation) 6. No significant abnormalities will be found at screening 7. Non smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months before study screening
Exclusion criteria
Exclusion criteria: 1. History of alcohol or drug abuse within 2 years prior to dosing 2. Eye disorder at admission 3. Current or past relevant disease concerning the cardio vascular system, respiratory system, kidneys, liver, blood, hormone system, nervous system, immunological system, skin or psychiatric condition 4. Having an illness within 5 day prior to receiving the first dose of study medication, e.g. nausea, vomiting, flu, 5. In the opinion of the physician any relevant abnormality on your ECG 6. Any medical condition which is of influence on the absorption, distribution, metabolism and excretion of the study medication 7. Use of over the counter drugs within 14 day of dosing, including herbal supplements (except for paracetamol and vitamins) 8. Use of prescription medication within 30 days before dosing 9. Have had an relevant allergic reaction on medication 10. Use of grapefruit or grapefruit containing, alcohol, caffeine containing products 11. products 48 hours before admission 12. Participation in a clinical trial within 2 months before dosing 13. Donation of blood within three months before dosing 14. Hepatitis B, C or HIV positive 15. If in the opinion of the physician the volunteer is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first aim of the study is to investigate the effect of telaprevir on the voncentration of LPV/rtv and ATV/rtv in the blood and the effect of LPV/rtv and ATV/rtv on the concentration telaprevir in the blood. . | — |
Secondary
| Measure | Time frame |
|---|---|
| The second aim is to investigate the safety and toleribility of the coadministartion of telaprevir and LPV/rtv and ATV/rtv in healthy volunteers. | — |
Countries
Netherlands
Outcome results
None listed