NL-OMON50412CompletedNot Applicable
An open-label study to characterize the absorption, distribution, metabolism and elimination of a single oral dose of 14C-leniolisib in healthy male subjects - Leniolisib ADME Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pharming Technologies B.V.
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
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
- •5. Subject has regular (daily) bowel movements;
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;
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