Study S001389

Pharmacokinetics, Safety, and Tolerability of BI 456906 Following Subcutaneous Injection in Male and Female Participants With Mild, Moderate and Severe Renal Impairment in Comparison to Participants With Normal Renal Function (Mono-centric, Open-label Study With Parallel Matched-pair Design)

ClinicalTrials.gov record

Registration

Registration: NCT06352411
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 42
Start: 2024-05-15
Primary completion: 2025-09-16
Lead sponsor: Boehringer Ingelheim
Conditions: Healthy; Renal Impairment
Interventions: COMBINATION_PRODUCT:BI 456906
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: REGISTRY:2023-508557-13-00; REGISTRY:U1111-1298-3135; NIH:2023

Registered primary outcomes

Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [up to Day 29]
Maximum measured concentration of BI 456906 in plasma (Cmax) [up to Day 29]

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