A bioequivalence study comparing 70 mg leniolisib capsules with leniolisib tablets in healthy volunteers - Leniolisib Bioequivalence study

Pharming Technologies B.V.0 sites20 target enrollmentStarted: TBDLast updated: April 15, 2024

Conditions

Trial Snapshot

No summary available.

•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
•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;

•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;

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