Clinical trial NCT05480475: 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
Official title: A Single-center, Open-label, Three-period, Fixed-sequence Design Study to Investigate the Effect of Daridorexant on the Pharmacokinetics of Dabigatran and Rosuvastatin in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-29
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Three-period, fixed-sequence design
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of dabigatran
timeFrame: 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).
measure: Cmax of rosuvastatin
timeFrame: 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).
Secondary outcomes:
Other outcomes:
measure: Time to reach Cmax (tmax) of dabigatran
timeFrame: 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).
measure: Tmax of rosuvastatin
timeFrame: 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).
measure: Area under the plasma concentration-time curve from zero to infinity (AUC0-inf) of dabigatran
timeFrame: 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).
measure: AUC0-inf of rosuvastatin
timeFrame: 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).
measure: Terminal half-life (t½) of dabigatran
timeFrame: 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).
measure: T½ of rosuvastatin
timeFrame: 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).
Locations:
city: Pilsen
country: Czechia
facility: CEPHA s.r.o.
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: