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Clinical Trials associated with BI-3000202 / Not yet recruitingPhase 1 A Phase I, Open-label, Single-dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of BI 3000202 in Adults
This study is open to healthy people and people with liver problems. Adults between 18 and 80 years can participate. The purpose of this study is to compare how a medicine called BI 3000202 is handled by the body in people with and without liver problems.
All participants take 1 tablet of BI 3000202. Participants with liver problems may also continue their regular treatment for their liver condition.
Participants are in the study for about 1 month. During this time, participants visit the study site about 11 times. Where possible, some of these visits may happen by phone. For some visits, participants stay at the study site overnight. Doctors regularly test the amount of BI 3000202 in the blood and check for any health problems.
Randomised, Placebo-controlled, Double-blind, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of Oral BI 3000202 in Patients With Moderate to Severe Systemic Lupus Erythematosus (SLE)
This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition.
Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE.
Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.
A Phase I, Open-label Trial in Two Parallel Parts to Investigate Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 3000202 (C-14) Administered as Oral Solution (Part A) and to Investigate Absolute Bioavailability (BA) of BI 3000202 Administered as Film Coated Tablet Together With an Intravenous Microtracer Dose of BI 3000202 (C-14) (Part B) in Healthy Male and Female Participants
The purpose of this study is to find out how quickly and to what extent BI 3000202 is processed in the body.
The purpose of Part A is to find out how 3000202 moves through and exits the body of healthy people. The purpose of Part B is to find out how much BI 3000202 gets into the blood when participants take it as a tablet compared with when they get it as an infusion.
Adults between 18 and 55 years of age can take part if the study doctor determines they are healthy.
The doctors regularly check participants' health. To assess the study endpoints, the study staff takes blood, urine, and stool samples.
100 Clinical Results associated with BI-3000202
100 Translational Medicine associated with BI-3000202
100 Patents (Medical) associated with BI-3000202
100 Deals associated with BI-3000202