Study S001662

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

ClinicalTrials.gov record

Registration

Registration: NCT06772532
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 30
Start: 2025-02-10
Primary completion: 2025-05-29
Lead sponsor: Boehringer Ingelheim
Conditions: Healthy
Interventions: COMBINATION_PRODUCT:BI 456906 - Formulation A; DRUG:BI 456906 - Formulation B; DRUG:BI 456906 - Formulation C
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: REGISTRY:2024-516529-30-00; REGISTRY:U1111-1310-7283

Registered primary outcomes

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

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