The purpose of the study is to determine how a single administration of rifampicin influences the uptake and breakdown of clazosentan. Furthermore, the safety and tolerability of clazosentan when administered after administration of rifampicin, will…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The pharmacokinetic parameters.
Secondary outcome
The safety endpoint parameters are frequency and severity of adverse events,
vital signs, electrocardiography (ECG),
safety laboratory tests and urinalysis.
Background summary
When bleeding occurs in the brain, the brain tissue responds by contracting the
blood vessels near the bleeding. This cramping of blood vessels can result in
local brain cells receiving not enough blood. The brain areas that receive too
little blood may in turn die. Clazosentan is being developed to prevent and/or
reverse cramping of blood vessels after a stroke.
Study objective
The purpose of the study is to determine how a single administration of
rifampicin influences the uptake and breakdown of clazosentan. Furthermore, the
safety and tolerability of clazosentan when administered after administration
of rifampicin, will be investigated.
Primary objective
To evaluate the influence of a single intravenous (i.v.) infusion of rifampicin
on the PK of clazosentan
Secondary objective
To evaluate the safety and tolerability of clazosentan when administered
following i.v. infusion of saline or rifampicin.
Study design
A single-center, randomized, double-blind, two-period cross-over study to
investigate the effect of rifampicin on the pharmacokinetics of clazosentan in
healthy male subjects.
Intervention
The study will start with a screening. At the screening a physical examination
will take place and a few other standard
medical assessments will be performed (ECG,vital signs). Furthermore a blood
and urine sample will be taken for
laboratory tests and an alcohol breathtest and drug screen will be done.
During the stay in the clinic the subject will receive the study medication ( a
single i.v. infusion of saline or rifampicin (600 mg) for 30 min in the morning
of Day 1 of Treatment A or Treatment B, respectively, prior to clazosentan 15
mg/h for 3 h.) and on several time points blood will be taken
and urine will be collected. The subjects will be asked for possible side
effects on regular basis. Furthermore several
safety assessments will be done frequently.
Finally, a follow-up (end of study) visit will take place and a follow-up phone
call will take place .
Study burden and risks
The risk to health at the chosen dose is limited, but the volunteers may
experience any of the side effects written in the ICF or symptoms that have not
reported before.
Volunteers health is closely monitored during the study to minimize these risks.
If the volunteers experience side effects, the investigator will treat them
where necessary, if new information is available on the safety of the study
medication, the volunteers are informed as soon as possible. The blood
collection procedure is not dangerous.
Hegenheimermattweg 91
Allschwil CH-4123
CH
Hegenheimermattweg 91
Allschwil CH-4123
CH
Listed location countries
Age
Inclusion criteria
Healthy male subjects aged between 18 and 65 years (inclusive) with a Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening. ;Further inclusion criteria can be found in the protocol section 3.2.2.
Exclusion criteria
1. Previous exposure to clazosentan.
2. Previous exposure to rifampicin within 3 months prior to Screening.
3. Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients. ;Further exclusion criteria can be found in the protocol section 3.2.3.
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 | EUCTR2018-001607-36-NL |
| CCMO | NL66167.056.18 |