Safety, Tolerability and Pharmacokinetics of BI 653048 H3PO4 Oral Drinking Solution in Healthy Male Volunteers

Phase 1 Completed 80 enrolled Boehringer Ingelheim

RandomizedParallel-groupSingle-blindTreatment

Summary

* Investigation of safety and tolerability of BI 653048 H3PO4 following the administration of single rising doses of an aqueous solution in healthy male subjects * Pharmacokinetic and pharmacodynamic characteristics of BI 653048, including the investigation of dose proportionality * Investigation of relative bioavailability of capsules versus aqueous solution

Timeline

Start: 2008-11
Primary completion: 2009-06
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	—	Oral

Indications

No indication recorded.