Activated Phosphoinositide 3-kinase DeltaSyndrome (APDS) Immune disorder
Conditions
Interventions
Subjects will receive 70 mg of 14C radioactively labeled leniolisib once (as an
oral solution of 50 milliliters (mL)).
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. Subject has regular (daily) bowel movements;
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 formulation, 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. The radiation exposure from the previous 3 year period is over 10 mSv for subjects who had been exposed to ionizing radiation above background as a result of their work with radiation as Category A (classified) workers or as a result of research studies they might have been involved in. Clinical (therapeutic or diagnostic) exposure will not be included; 4. An occupation which requires monitoring for radiation exposure, nuclear medicine procedures or excessive x-rays within the past 12 months; 5. History of clinically significant endocrine, gastrointestinal, cardiovascular, haematological, hepatic, immunological, renal, respiratory, neoplastic or genitourinary abnormalities or diseases;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the total recovery and relative excretion of radioactivity in urine and feces after a single dose of 70 mg 14C-leniolisib, containing 40 µCi of 14C-radioactivity administered as a solution for oral administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the plasma PK parameters of total 14C-radioactivity and of leniolisib; To evaluate the safety profile of a single 70 mg dose of 14C-leniolisib. | — |
Countries
Netherlands
Outcome results
None listed