This Study Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357

Phase 1 Completed 83 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy volunteers for up to 28 days.

Timeline

Start: 2018-01-09
Primary completion: 2018-08-24
Completion: 2018-08-30

Publications

Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 730357	Unknown	25 mg	Oral
Subject	BI 730357	Unknown	50 mg	Oral
Subject	BI 730357	Unknown	100 mg	Oral
Subject	BI 730357	Unknown	200 mg	Oral
Subject	BI 730357	Unknown	400 mg	Oral
Subject	Midazolam	Small molecule	75 ug	Oral

This Study Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357

Summary

Timeline

Publications

Drugs

Indications