NCT03875001

A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men

Completed Phase 1 Results posted Last updated 26 February 2025

What this trial tests

Phase 1 trial testing Placebo in Healthy in 24 participants. Completed in 20 July 2019.

Timeline

25 March 2019

Primary endpoint
20 July 2019

20 July 2019

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	25 March 2019
Primary completion	20 July 2019
Estimated completion	20 July 2019
Sites	1 location across Japan

Drugs / interventions tested

• Placebo
• Dose group 1 - 50 mg BI 1358894 — full drug profile →
• Dose group 2 - 100 mg BI 1358894 — full drug profile →
• Dose group 3 - 200 mg BI 1358894 — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 20 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Subjects With Drug Related Adverse Events (AEs). Primary · Up to 14 days for 50 mg BI 1358894, 100 mg BI 1358894 and placebo. Up to 33 days for 200 mg BI 1358894.

Percentage of subjects with drug related adverse events (AEs).

Group	Value	95% CI
Placebo	0
Dose Group 1 - 50 mg BI 1358894	0
Dose Group 2 - 100 mg BI 1358894	16.7
Dose Group 3 - 200 mg BI 1358894	33.3

Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz). Secondary · 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.

AUC0-tz (area under the concentration-time curve of BI 1358894 in plasma over the time interval from the time of administration to the last quantifiable data time point tz).

Group	Value	95% CI
Dose Group 1 - 50 mg BI 1358894	6320	± 15.0
Dose Group 2 - 100 mg BI 1358894	13700	± 23.5
Dose Group 3 - 200 mg BI 1358894	32200	± 26.0

Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) Secondary · 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.

Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity.

Group	Value	95% CI
Dose Group 1 - 50 mg BI 1358894	6960	± 16.5
Dose Group 2 - 100 mg BI 1358894	15800	± 20.8
Dose Group 3 - 200 mg BI 1358894	33600	± 26.1

Maximum Measured Concentration of BI 1358894 in Plasma (Cmax) Secondary · 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.

Maximum measured concentration of BI 1358894 in plasma.

Group	Value	95% CI
Dose Group 1 - 50 mg BI 1358894	224	± 14.2
Dose Group 2 - 100 mg BI 1358894	470	± 22.3
Dose Group 3 - 200 mg BI 1358894	904	± 10.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Dose Group 1 - 50 mg BI 1358894

Serious: 0/6 (0%)

Deaths: 0/6

Dose Group 2 - 100 mg BI 1358894

Serious: 0/6 (0%)

Deaths: 0/6

Dose Group 3 - 200 mg BI 1358894

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (3 terms — click to expand)

Reaction	System	Placebo	Dose Group 1 - 50 mg BI 13…	Dose Group 2 - 100 mg BI 1…	Dose Group 3 - 200 mg BI 1…
Dizziness	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Sleep disorder	Psychiatric disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03875001 adverse events section.

Sponsor's own description

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1358894 in healthy male subjects following oral administration of single rising doses.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety, Tolerability, and Pharmacokinetics of Oral BI 1358894 in Healthy Japanese Male Volunteers.
   Yoon J, Sharma V, Harada A. · · 2024 · cited 6× · PMID 38656736 · DOI 10.1007/s40261-024-01357-z
2. CNS Summit 2023: Abstracts of Poster Presentations
   · 2023