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

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT05480475
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Dabigatran etexilate — DRUG
    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.
  • Rosuvastatin — DRUG
    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.
  • Daridorexant — DRUG
    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.

Study Details

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

Key Dates

Start date
Sep 3, 2022
Status verified
Nov 2022
Primary completion
Sep 17, 2022
Completion
Sep 17, 2022

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Study treatment (Period 1, 2, and 3)
    Period 1: Treatment A1 - dabigatran etexilate; Treatment A2 - rosuvastatin Period 2: Treatment B - daridorexant Period 3: Treatment C1 - dabigatran etexilate and daridorexant; Treatment C2 - rosuvastatin and daridorexant

Primary Outcome Measure

Maximum plasma concentration (Cmax) of dabigatran [ Time Frame: 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). ]

Related Studies