Activated Phosphoinositide 3-kinase Delta Syndrome (APDS) Immune disorder
Conditions
Interventions
Subjects will receive leniolisib twice: once as a capsule and once as a tablet.
Each dose of leniolisib will be 70 milligram.
Sponsors
Pharming Technologies B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male between 18 and 45 years of age (both inclusive) at the screening visit; 2. Subject has Dutch or English as native language; 3. Body mass index between 18.5 and 30.0 kg/m2 (both inclusive); 4. Subject is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and prior to administration of the initial dose of study drug; 5. Subjects, if not surgically sterilized, must agree to use at least 1 form of contraception and not donate sperm from first admission to the clinical research center until after the follow-up. For this study, contraception for the male subject (and his female partner) is defined as using hormonal contraceptives, an intrauterine device, a diaphragm, a cervical cap, or a condom. Total abstinence, in accordance with the lifestyle of the subject, is also acceptable;
Exclusion criteria
Exclusion criteria: 1. Employee of PRA or the Sponsor; 2. History of known sensitivity or intolerability to leniolisib or to any related compound or excipients in the formulations, or history of significant multiple and/or severe allergies (including latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food; 3. History of clinically significant endocrine, gastrointestinal, cardiovascular, haematological, hepatic, immunological, renal, respiratory, neoplastic or genitourinary abnormalities or diseases; 4. Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study; 5. Positive polymerase chain reaction (PCR) test for SARS-CoV-2 at admission or within 8 weeks prior to screening or check-in, or contact with COVID-19 positive (or suspected) persons within 14 days prior to dosing;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if 70 mg of leniolisib administered as a single dose of the hard gelatin capsule (HGC) formulation is bioequivalent (within 0.80-1.25 as the bioequivalence boundaries) to 70 mg of leniolisib administered as a single 70-mg film-coated tablet (FCT). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the tolerability of leniolisib after both doses. | — |
Countries
Netherlands
Outcome results
None listed