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

Completed

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

• Registration Number: NL-OMON49922
• Lead Sponsor: Pharming Technologies B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-03-31
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine if 70 mg of leniolisib administered as a single dose of the hard<br /><br>gelatin capsule (HGC) formulation is bioequivalent (within 0.80-1.25 as the<br /><br>bioequivalence boundaries) to 70 mg of leniolisib administered as a single<br /><br>70-mg film-coated tablet (FCT).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the tolerability of leniolisib after both doses.</p><br>