The purpose of the study is to determine how a single administration of rifampicin influences the uptake and breakdown of ACT-246475. Furthermore, the safety and tolerability of ACT-246475 when administered after administration of rifampicin, will…
ID
Source
Brief title
Condition
- Myocardial disorders
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 somebody has a heart attack, it is important that this person is treated
as soon as possible so the heart gets damaged as little as possible. ACT-246475
is a compound that is being developed to be used as an emergency treatment for
a heart attack.
Study objective
The purpose of the study is to determine how a single administration of
rifampicin influences the uptake and breakdown of ACT-246475. Furthermore, the
safety and tolerability of ACT-246475 when administered after administration of
rifampicin, will be investigated.
Primary objective
To evaluate the effect of a single intravenous (i.v.) dose of rifampicin on the
PK of ACT-246475 in healthy subjects.
Secondary objective
To evaluate the safety and tolerability of ACT-246475 when administered
following i.v. infusion of saline or rifampicin in healthy subjects.
Study design
A single-center, randomized, double-blind, two-period, cross-over study to
investigate the effect of a single intravenous dose of rifampicin on the
pharmacokinetics of ACT-246475 in healthy subjects.
Intervention
ACT-246475 + saline or
ACT-246475 + rifampicin
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
been 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 and female 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 ACT-246475.
2. Previous exposure to rifampicin within 3 months prior to Screening.
3. Known hypersensitivity to P2Y12 receptor antagonists or rifampicin or to any of the rifamycins, 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 | EUCTR2018-004226-28-NL |
| CCMO | NL68150.056.18 |