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. The secondary objective is to…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
This new investigational drug called telaprevir is in process of development
for the treatment of patients who are infected with hepatitis C virus (HCV).
Telaprevir is a so-called "protease inhibitor", a new investigational class of
drugs that works by blocking an enzyme (called "protease") that the hepatitis C
virus needs for its reproduction. Telaprevir is being studied for the treatment
of hepatitis C in association with pegylated interferon and ribavirin, and the
association of the three drugs may be more efficient at curing people than the
standard combination alone.
Study objective
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. 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.
Study design
Open label, randomised, cross-over trial
Study burden and risks
The risks of participation in this trial is associated with possible adverse
events of telaprevir, DRV/rtv and fAPV/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.
Dr. Paul Janssenweg 150
5026 RH Tilburg
the Netherlands
Dr. Paul Janssenweg 150
5026 RH Tilburg
the Netherlands
Listed location countries
Age
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
-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
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 | EUCTR2008-002104-26-NL |
| CCMO | NL23172.072.08 |