Healthy Subjects
Conditions
Keywords
pharmacokinetic, interaction
Brief summary
The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in the blood) of ACT-541468
Detailed description
Because ACT-541468 appears to be mainly metabolized by CYP3A4, it is deemed of interest to investigate the potential influence of diltiazem, a well-known CYP3A4 inhibitor on the pharmacokinetic profile of ACT-541468. Safety of the concomitant administration of the two drugs will also be assessed
Interventions
DRUGACT-541468
Oral capsule (25 mg) as single dose
DRUGDiltiazem
Two oral capsules (2 x 120 mg) once daily from Day 1 to Day 7
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent * Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening * Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests
Exclusion criteria
* Any contraindication to the study drugs * History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs * History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score \< 0 * Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) of ACT-541468 | From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA) | Cmax will be directly derived from the plasma concentration time curves of ACT-541468 |
| Time to reach Cmax of ACT-541468 in plasma | From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA | tmax will be directly derived from the plasma concentration time curves of ACT-541468 |
| Area under the plasma concentration-time curve (AUC) of ACT-541468 | From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA) | AUC will be calculated for the following time frame: from time zero to the last measured concentration above the limit of quantification and from time zero to infinitiy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of safety events of interest | From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA) | Events of interest are any abnormalities in ECG, vital signs or laboratory test results |
| Incidence of adverse events | From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA) | Number of participants with any adverse events, including laboratory abnormalities |
Countries
Germany
Outcome results
None listed