Healthy
Conditions
Brief summary
A study to examine the effect of daridorexant on the way the body absorbs, distributes, and gets rid of dabigatran and rosuvastatin in healthy male subjects
Interventions
DRUGDabigatran etexilate
On Day 1 (Treatment A1) and on Day 9 (Treatment C1) a single oral dose of 75 mg dabigatran etexilate will be administered under fasted conditions.
DRUGRosuvastatin
On Day 3 (Treatment A2) and on Day 11 (Treatment C2) a single oral dose of 10 mg rosuvastatin will be administered under fasted conditions.
DRUGDaridorexant
On Day 7 and Day 8 (Treatment B), on Day 9 and Day 10 (Treatment C1), and on Day 11 through 14 (Treatment C2) subjects will receive 50 mg daridorexant o.d. under fasted conditions.
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Three-period, fixed-sequence design
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent in a language understandable to the subject prior to any study-mandated procedure. 2. Healthy male subject aged between 18 and 45 years (inclusive) at Screening.
Exclusion criteria
1. Known hypersensitivity to daridorexant, rosuvastatin, and/or dabigatran etexilate, or treatments of the same class, or any of its/their excipients. 2. Any history of hemorrhagic disease, whether or not hereditary. 3. Any history of complications with bleeding after surgery or tooth extractions and/or frequent nasal, hemorrhoidal, or gingival bleeding. 4. Activated partial thromboplastin time (aPTT) and/or thrombin time (TT) \< 0.8 or \> 1.2 at Screening. 5. Clinically relevant findings on the physical examination at Screening. 6. Clinically relevant findings on 12-lead ECG, recorded after 5 min in a supine position at Screening. 7. Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax) of dabigatran | Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days). |
| Cmax of rosuvastatin | Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days). |
Other
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from zero to infinity (AUC0-inf) of dabigatran | Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days). |
| AUC0-inf of rosuvastatin | Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days). |
| Time to reach Cmax (tmax) of dabigatran | Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days). |
| T½ of rosuvastatin | Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days). |
| Terminal half-life (t½) of dabigatran | Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days). |
| Tmax of rosuvastatin | Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days). |
Countries
Czechia
Outcome results
None listed