This study involves research and the objective of this study is to investigate the effect of esomeprzole on the single-dose pharmacokinetics (i.e., how a drug moves through the body) of telaprevir. And to obtain additional data regarding the safety…
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetics
For more specifications see the protocol.
Secondary outcome
To investigate the safety and tolerability.
For more specifications see the protocol.
Background summary
The new investigational drug called telaprevir is in process of development for
the treatment of patients who are infected with hepatitis C virus.
This study involves research and the objective of this study is to investigate
the effect of esomeprzole on the single-dose pharmacokinetics (i.e., how a drug
moves through the body) of telaprevir. And to obtain additional data regarding
the safety and tolerability of telaprevir.
From previous studies with a total of 250 healthy subjects, and 472 subjects
with genotype I hepatits C infection, we learned that telaprevir, administered
aloneor in combination with pegylated interferon and ribavirin, is usualy well
tolerated.
Across all studies in healthy subjects, the most frequent adverse events in
subject dosed with telaprevir (for up to 28 days) were nausea, diarrhea,
headache, pruritus, and rash. In two phase II clinical studies in 327 hepatitis
C infected subjects who were treated with telaprevir 750 mg three times daily
for up to 12 weeks in combination with pegylated interferon and ribavirin, the
most frequent adverse events were: fatigue, infuenza-like illeness, asthenia,
headache, insomnia, gastrointestinal disorders such as nausea and diarrhea, and
skin rash and pruritus. Most adverse experiences were considered mild in
severity.
In total 24 healthy male and female, aged between 18 and 55 years of age will
be selected in this study
Study objective
This study involves research and the objective of this study is to investigate
the effect of esomeprzole on the single-dose pharmacokinetics (i.e., how a drug
moves through the body) of telaprevir. And to obtain additional data regarding
the safety and tolerability of telaprevir.
Study design
In total 24 healthy male and female, aged between 18 and 55 years of age will
be selected in this study
Study procedures:
- Screening visit (medical screening).
- Study period: This study will consist of two treatments; treatment A and
treatment B in randomized order. For treatment A the subject will be admitted
to the testing facility for 2 nights. During treatment A the subject will
recieve a single dose of telaprevir on day 1. During treatment B the subject
will be admitted to the testing facility for 1 night. After 2 days at home,
they will return for 2 short visits. Thereafter they will be admitted to the
testing facility for 2 nights. In treatment B the subjects will receive
esomeprazole from day 1 to day 6 and a single dose of Telaprevir on day 6. When
the subjects take esomeprazole at home, they will note the intake in a diary.
Between these treatment a washout period is needed of at least 1 week.
- Follow up: a follow-up will take place after about 1 week and 1 month afther
the last drug intake.
The study will be performed for a total duration of 10 weeks.
Study burden and risks
The risks are small. The drug will be in a controled environment.
At screening a physical examination will be performed and a few standard
assessments will be performed (ECG, heart rate, bloodpressure). Furthermore a
blood and urine sample will be taken.
During treatment A the subject will recieve a single dose of telaprevir on day
1. During. In treatment B the subjects will receive esomeprazole from day 1 to
day 6 and a single dose of Telaprevir on day 6. Both drugs will be taken as a
tablet.
During the stay in the clinic on different moments a ECG will be performed and
the heartrate en bloodpressure will be measured. Furthermore blood and urine
samples will be taken.
From previous studies with a total of 250 healthy subjects, and 472 subjects
with genotype I hepatits C infection, we learned that telaprevir, administered
aloneor in combination with pegylated interferon and ribavirin, is usualy well
tolerated.
Across all studies in healthy subjects, the most frequent adverse events in
subject dosed with telaprevir (for up to 28 days) were nausea, diarrhea,
headache, pruritus, and rash. In two phase II clinical studies in 327 hepatitis
C infected subjects who were treated with telaprevir 750 mg three times daily
for up to 12 weeks in combination with pegylated interferon and ribavirin, the
most frequent adverse events were: fatigue, infuenza-like illeness, asthenia,
headache, insomnia, gastrointestinal disorders such as nausea and diarrhea, and
skin rash and pruritus. Most adverse experiences were considered mild in
severity.
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland
Listed location countries
Age
Inclusion criteria
Male or female, aged between 18-55 years of age (extremes included).
Females, postmenopausal for at least 2 years, or posthysterectomy or post-tubal ligation.
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.
A body mass index of 18 to 30 kg/m^2 (extremes included)
Exclusion criteria
Clinical significant abnormalities at screening
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 | EUCTR2007-007868-17-NL |
CCMO | NL22008.056.08 |