Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers

Phase 1 Completed 20 enrolled Boehringer Ingelheim

RandomizedParallel-groupSingle-blindTreatment

Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses. The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing

Timeline

Start: 2017-06-30
Primary completion: 2018-02-19
Completion: 2018-02-19

Publications

Jungnik A, Arrubla Martinez J, Plum-Morschel L, Kapitza C, Lamers D, Thamer C, Scholch C, Desch M, Hennige AM. Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906. Diabetes Obes Metab. 2023 Apr;25(4):1011-1023. doi: 10.1111/dom.14948. Epub 2023 Jan 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Survodutide	Protein / enzyme biologic	—	Subcutaneous

Indications

No indication recorded.