Activated Phosphoinositide 3-Kinase Delta Syndrome research hub
5 indexed studies · 5 currently recruiting
- recruitingTherapeutic confirmatory (Phase III)
An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 1 to 6 Years) with APDS (Activated Phosphoinositide 3-Kinase Delta Syndrome) Followed by an Open-label Long-term Extension
This clinical trial is testing a medicine called leniolisib for young children aged 1 to 6 with a rare immune condition called APDS. Children with APDS often have frequent infections and swollen glands. Doctors want to see if the medicine is safe, easy to take, and improves their health.
Portugal · Spain - 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.
France - recruitingHuman Pharmacology (Phase I)- Other
An open-label, single-dose, parallel-group study to evaluate the plasma pharmacokinetics of leniolisib in subjects with impaired hepatic function and in subjects with normal hepatic function
This study is looking at how a new medicine, leniolisib, moves through the body in people with a rare condition called Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS). We want to see if liver problems affect how the medicine works, comparing it to people with healthy livers.
Germany · Hungary - recruitingHuman Pharmacology (Phase I)- Other
An open-label cocktail drug-drug interaction (DDI) clinical study to assess the effect of multiple oral dosing with leniolisib on the pharmacokinetics (PK) of caffeine, midazolam, rosuvastatin, furosemide, and metformin in healthy subjects
This study is testing a new medicine called leniolisib, which is for patients with a condition called Activated PI3K Delta Syndrome. It aims to see how taking leniolisib affects other common medicines in healthy volunteers, to make sure it's safe to use with other treatments.
Germany - 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.
Germany