Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 653048 BS H3PO4 Capsule Multiple Rising Doses in Healthy Male Volunteers

Phase 1 Completed 140 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The objectives of the trial were to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 653048 BS H3PO4 compared with prednisolone.

Timeline

Start: 2009-10
Primary completion: 2010-03
Completion: —

Publications

Harcken C, Scholl P, Nabozny G, Thomson D, Bianchi D. Clinical profile of the functionally selective glucocorticoid receptor agonist BI 653048 in healthy male subjects. Expert Opin Investig Drugs. 2019 May;28(5):489-496. doi: 10.1080/13543784.2019.1599859. Epub 2019 Apr 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 653048	Small molecule	25 mg	—
Subject	BI 653048	Small molecule	200 mg	—
Comparator	Prednisolone	Other / unclassified	—	—

Indications

No indication recorded.