Idorsia Pharmaceuticals Ltd.
A study to investigate the effect of itraconazole on the way the body absorbs, distributes, and gets rid of ACT-1004-1239 given as a single dose of 10 mg to healthy male subjects
Healthy
ACT-1004-1239 (10 mg)
Itraconazole (200 mg, o.d.)
Phase 1
Study Type : | Interventional |
Estimated Enrollment : | 16 participants |
Masking : | None (Open Label) |
Primary Purpose : | Other |
Official Title : | A Single-center, Open-label, Fixed-sequence Study to Investigate the Effect of Multiple-dose Itraconazole on the Pharmacokinetics of a Single Dose of 10 mg ACT-1004-1239 in Healthy Male Subjects |
Actual Study Start Date : | October 1, 2022 |
Estimated Primary Completion Date : | October 20, 2022 |
Estimated Study Completion Date : | October 20, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Investigational and interaction treatment ACT-1004-1239 (10 mg) will be administered on Day 1 (in Treatment A) and Day 9 (in Treatment B2). Itraconazole (200 mg, o.d.) will be administered from Day 6 until Day 13. On Day 9, itraconazole will be administered concomitantly with ACT-1004-1239. |
Drug: ACT-1004-1239 (10 mg) Drug: Itraconazole (200 mg, o.d.) |
Ages Eligible for Study: | 18 Years to 55 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
BlueClinical Phase 1
Porto, Portugal, 4250-449