A six-way relative bioavailability study comparing 10, 30, 40 and 50 mg leniolisib film coated tablets and 30 mg film coated granules with 70 mg film coated tablet in healthy volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508880-61-00

Acronym

LE 1102

Enrollment

Registered

2024-02-28

Start date

2024-03-06

Completion date

2024-05-26

Last updated

2024-02-28

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

Brief summary

The ratio of geometric least square means between the five test formulations and the reference formulation for: • Dose normalized maximum observed drug concentration (Cmax); • Dose normalised area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC0-tlast); • Dose normalised AUC from time zero to infinity (AUC0-∞)

Detailed description

Incidence of treatment-emergent adverse events (TEAEs) comparison between the five test formulations and the reference formulation.

Interventions

DRUGCDZ173/Leniolisib

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The ratio of geometric least square means between the five test formulations and the reference formulation for: • Dose normalized maximum observed drug concentration (Cmax); • Dose normalised area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC0-tlast); • Dose normalised AUC from time zero to infinity (AUC0-∞)	—

Secondary

Measure	Time frame
Incidence of treatment-emergent adverse events (TEAEs) comparison between the five test formulations and the reference formulation.	—

Countries

Germany

Outcome results

None listed

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