The first aim of the study is to investigate the effect of telaprevir on the concentration of LPV/rtv and ATV/rtv in the blood and the effect of LPV/rtv and of ATV/rtv the concentration of telaprevir in the blood.The second aim is to investigate the…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
The second aim is to investigate the safety and toleribility of the
coadministartion of telaprevir and LPV/rtv and ATV/rtv in healthy volunteers.
Background summary
The investigational drug telaprevir is being developed in order to be used in
the future to treat patients with Hepatitis C. Telaprevir is not approved by
the US Food and Drug administration and other European governmental department.
This explains why the investigational product can only be used in this trial.
Up to now, telaprevir has been given to approximately 300 healthy volunteers
and moreover than 600 Hepatitis C patients within a finished or ongoing trial.
Telaprevir belong to the group of antivirals, which can be used in combination
with other registered medication for the treatment of Hepatitis C. Lopinavir
(LPV) and atazanavir (ATV) are prescribed medication used for the treatment of
HIV (human immunodeficiency virus). This medication will be given in low doses
and always in combination with a low dose ritonavir (rtv).
The comedication with ritonavir leads to a better concentration of LPV and ATV
in the blood and to a better tolerability of this medicines. The aim of this
study is to obtain more information about the recommended dose for the
comedication of these medicines to treat patients with both Hepatitis C and
HIV.
Study objective
The first aim of the study is to investigate the effect of telaprevir on the
concentration of LPV/rtv and ATV/rtv in the blood and the effect of LPV/rtv
and of ATV/rtv the concentration of telaprevir in the blood.
The second aim is to investigate the safety and toleribility of the
coadministration of telaprevir and LPV/rtv and ATV/rtv in healthy volunteers.
Study design
Two panels of 20 healthy male and female volunteers will be participating in
this trial. The study will consist of a screening and two parts per panel. One
of the parts will consist of an admission of 3 days and 2 short visits. The
other part will consist of an admission 4 of days, an admission of 7 or 8 days
and 3 short visits. Finally there will be 2 follow ups. There will be a period
of minimal 13 days between the two parts.
Volunteers in panel 1 will receive treatments A&BB. Volunteers in panel 2 will
receive treatments C&D. The order of treatments in a panel will be based on
chance.
Treatment A, Panel 1:
- 750 mg telaprevir every 8 hours from Day 1 to Day 9 and a morning dose on Day
10.
Treatment B, Panel 1:
- 400/100 mg LPV/rtv twice daily from Day 1 to Day 23 and a morning dose on Day
24.
- 750 mg telaprevir every 8 hours from Day 11 to Day 20 and 750 mg telaprevir
every 12 hours from Day 21 to Day 23 and a morning dose on Day 24.
Treatment C, Panel 2:
- 750 mg telaprevir every 8 hours from Day 1 to Day 9 and a morning dose on Day
10.
Treatment D, Panel 2:
- 300/100 mg ATV/rtv once daily from Day 1 to Day 24
- 750 mg telaprevir every 8 hours from Day 11 to Day 20 and 750 mg telaprevir
every 12 hours from Day 21 to Day 24
Study burden and risks
The risks of participation in this trial is associated with possible adverse
events of telaprevir, LPV/rtv and ATV/rtv. The burden for the participant is
also associated with the admission to the unit, venapunction and insertion of
canule. All subjects will be carefully followed on any adverse events and will
be under the supervision of experienced physicians and study personnel.
Genraal de Wittelaan L 11B3
2800 Mechelen
België
Genraal de Wittelaan L 11B3
2800 Mechelen
België
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-003547-79-NL |
| CCMO | NL18745.072.07 |