Study S001238

Relative Bioavailability of Two BI 456906 Formulations After Subcutaneous Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)

ClinicalTrials.gov record

Registration

Registration: NCT07071974
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 16
Start: 2025-07-28
Primary completion: 2025-10-07
Lead sponsor: Boehringer Ingelheim
Conditions: Healthy
Interventions: COMBINATION_PRODUCT:BI 456906 formulation A; DRUG:BI 456906 formulation B2
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: REGISTRY:2025-521419-37-00; REGISTRY:U1111-1319-7116; NIH:2025

Registered primary outcomes

AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [Up to 22 days.]
Cmax (maximum measured concentration of the analyte in plasma) [Up to 22 days.]

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