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An open-label, single-dose, parallel-group study to evaluate the plasma pharmacokinetics of leniolisib in subjects with impaired hepatic function and in subjects with normal hepatic function

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508519-22-00
Acronym
LE 6101
Enrollment
48
Registered
2024-01-10
Start date
2024-01-26
Completion date
2025-11-09
Last updated
2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Activated Phosphoinositide 3-Kinase Delta Syndrome

Interventions

None listed

Sponsors

Pharming Technologies B.V.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Countries

Germany, Hungary

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026