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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 7, 2021

Primary Completion Date

July 1, 2021

Study Completion Date

July 1, 2021

Conditions
Healthy
Interventions
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.

Trial Locations (1)

2333 CL

Centre Human Drug Research, Leiden

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

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 | Biotech Hunter | Biotech Hunter