An open-label study to characterize the absorption, distribution, metabolism and elimination of a single oral dose of 14C-leniolisib in healthy male subjects

Completed

• Conditions: Activated Phosphoinositide 3-kinase DeltaSyndrome (APDS); Immune disorder; 10021429

• Registration Number: NL-OMON50412
• Lead Sponsor: Pharming Technologies B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-03-14
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the total recovery and relative excretion of radioactivity in<br /><br>urine and feces after a single dose of 70 mg 14C-leniolisib, containing 40 µCi<br /><br>of 14C-radioactivity administered as a solution for oral administration. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the plasma PK parameters of total 14C-radioactivity and of<br /><br>leniolisib;<br /><br>To evaluate the safety profile of a single 70 mg dose of 14C-leniolisib.</p><br>