A Study in Healthy Men to Test How Different Doses of BI 474121 Are Taken up and How They Influence the Amount of a Molecular Messenger (cGMP) in the Spinal Fluid

Summary

The main objectives of this trial are: * To evaluate the effect of BI 474121 on cyclic guanosine monophosphate (cGMP) levels in cerebrospinal fluid (CSF) * To assess the exposure of BI 474121 in CSF relative to plasma * To determine the exposure effect relationship in CSF with different oral doses of BI 474121

Timeline

Start

2021-01-07

Primary completion

2021-07-01

Completion

2021-07-01

Outcome

Missed primary endpoint

registry analysis (other test); Placebo vs 2.5 Milligram (mg) BI 474121; p = 0.3941; Ratio 1.29 (90% CI 0.78 to 2.13); ANCOVA NCT04672954 ↗

registry analysis (other test); Placebo vs 10 Milligram (mg) BI 474121; p = 0.1089; Ratio 1.66 (90% CI 0.99 to 2.79); ANCOVA NCT04672954 ↗

registry analysis (other test); Placebo vs 20 Milligram (mg) BI 474121; p = 0.6308; Ratio 1.14 (90% CI 0.71 to 1.85); ANCOVA NCT04672954 ↗

registry analysis (other test); Placebo vs 40 Milligram (mg) BI 474121; p = 0.0690; Ratio 1.75 (90% CI 1.06 to 2.89); ANCOVA NCT04672954 ↗

Publications

• van Kraaij S, Goeldner RG, Rosenbrock H, Groeneveld GJ, Kremer P, Schaible J, Zambori J, Schultheis C. Effects of the phosphodiesterase 2 inhibitor BI 474121 on central nervous system cyclic guanosine monophosphate concentrations: Translational studies. Br J Clin Pharmacol. 2024 Oct;90(10):2517-2528. doi: 10.1111/bcp.16137. Epub 2024 Jun 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 474121	Unknown	2.5 mg	Oral
Subject	BI 474121	Unknown	10 mg	Oral
Subject	BI 474121	Unknown	20 mg	Oral
Subject	BI 474121	Unknown	40 mg	Oral

Indications

No indication recorded.