CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
2.5 milligram (mg) BI 474121from record
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Search/NCT04672954
NCT04672954Phase 1Completed
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Pharmacokinetics and Pharmacodynamic Effects of Different Single Oral Doses of BI 474121 in Healthy Male Subjects

Boehringer Ingelheim·interventional·Posted Dec 17, 2020·Updated Mar 8, 2024

In Brief

A Phase 1 clinical trial evaluating Placebo, 2.5 milligram (mg) BI 474121, and 3 other interventions for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedDec 17, 2020
Enrollment StartJan 7, 2021
Primary CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.5 years ago

Interventions

Placebodrug

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.

2.5 milligram (mg) BI 474121drug

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.

10 milligram (mg) BI 474121drug

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.

20 milligram (mg) BI 474121drug

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.

40 milligram (mg) BI 474121drug

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.