- Ongoing, recruitingHuman Pharmacology (Phase I)- Other
A six-way relative bioavailability study comparing 10, 30, 40 and 50 mg leniolisib film coated tablets and 30 mg film coated granules with 70 mg film coated tablet in healthy volunteers
This study is looking at different versions of a new medicine, leniolisib, for a rare condition called Activated Phosphoinositide 3-Kinase Delta Syndrome. It aims to see how well different forms and doses of the medication are absorbed and used by the body in healthy adult volunteers.
For: Activated Phosphoinositide 3-Kinase Delta SyndromeGermany - Ongoing, recruitingTherapeutic confirmatory (Phase III)
An Open-Label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 4 to 11 Years) With APDS (Activated Phosphoinositide 3-Kinase Delta Syndrome) Followed by an Open-Label Long-Term Extension
This study looks at a new medicine called leniolisib for children aged 4-11 with APDS, a rare immune condition. It checks if the medicine is safe and helps improve their health, including reducing swollen glands.
For: Activated Phosphoinositide 3-Kinase Delta SyndromeFrance