NCT04672954

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

Pharmacokinetics and Pharmacodynamic Effects of Different Single Oral Doses of BI 474121 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo	Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
DRUG	2.5 milligram (mg) BI 474121	2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
DRUG	10 milligram (mg) BI 474121	10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
DRUG	20 milligram (mg) BI 474121	20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
DRUG	40 milligram (mg) BI 474121	40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.

Timeline

• Start date: 2021-01-07
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2020-12-17
• Last updated: 2024-03-08
• Results posted: 2024-03-08

Locations

1 site across 1 country: Netherlands