Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Japanese and Chinese Male Subjects (Randomized, Double-blind, Placebo-controlled Design Within Dose Groups)

To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy Chinese and Japanese male subjects following the administration of single rising oral doses and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809 after single dosing of product.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BI 425809

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea
    • 1346.4.82001 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Age 20 to 45 years (incl.)
• BMI 18.5 to 25 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
• Chinese ethnicity, Japanese ethnicity according to the following criteria:
• Chinese: ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
• Japanese: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan

Exclusion criteria:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
• Repeated measurement of systolic blood pressure <90 or >140 mmHg, or diastolic blood pressure <50 or >90 mmHg, or PR <50 or >90
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
• Diseases of the central nervous system (including by not limited to any kind of seizures or stroke), other neurological disorders or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
• Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half- lives of the respective drug prior to administration of trial medication
• Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
• Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking on specified trial days
• Alcohol abuse (consumption of more than 20 g per day)
• Drug abuse or positive drug screening
• Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
• Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
• Inability to comply with dietary regimen of trial site
• At screening, a marked baseline prolongation of QT/QTcF interval (such as repeated demonstration of a QTcF interval greater than 450 ms or any other relevant ECG finding
• A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
• Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
• Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
• Evidence or history of macular degeneration or any abnormal finding in color discrimination test, and any other clinically significant ophthalmic disorders based on the investigator's discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment.	Drug: Placebo; Single dose matching BI 425809 administered as tablets orally with 240 mL of water after an overnight fast of at least 10 hours.
Experimental: BI 425809 10 mg Tablet; The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet*2) orally with 240 mL water after an overnight fast of at least 10 hours.	Drug: BI 425809; Single dose administered orally as tablets with 240 mL water after an overnight fast of at least 10 hours; Other Names: Iclepertin
Experimental: BI 425809 25 mg Tablet; The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours.	Drug: BI 425809; Single dose administered orally as tablets with 240 mL water after an overnight fast of at least 10 hours; Other Names: Iclepertin
Experimental: BI 425809 50 mg Tablet; The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet*2) orally with 240 mL water after an overnight fast of at least 10 hours.	Drug: BI 425809; Single dose administered orally as tablets with 240 mL water after an overnight fast of at least 10 hours; Other Names: Iclepertin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Drug-Related Adverse Events (AEs)	This outcome measure presents the number of subjects with drug-related adverse events.	Up to 11 days after drug administration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)	This outcome measure presents maximum measured concentration of BI 425809 in plasma (Cmax).	-2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Area Under the Concentration (AUC0-∞) Time Curve of BI 425809	This outcome measure presents area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).	-2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Area Under the Concentration (AUC0-tz) Time Curve of BI 425809	This outcome measure presents area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration (AUC0-tz).	-2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Tmax of BI 425809	This outcome measure presents time from dosing to the maximum concentration of BI 425809 in plasma (tmax).	-2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
t1/2 of BI 425809	This outcome measure presents terminal half-life of BI 425809 in plasma (t1/2).	-2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

General Publications

• Tsuda Y, Ugai H, Wunderlich G, Shin JG. Pharmacokinetics of Single Doses of BI 425809 in Healthy Chinese and Japanese Subjects: A Randomized Study. Clin Ther. 2019 May;41(5):961-971. doi: 10.1016/j.clinthera.2019.03.014. Epub 2019 Apr 17.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2015
• Primary Completion (Actual): August 6, 2015
• Study Completion (Actual): August 6, 2015

Study Registration Dates

• First Submitted: March 6, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimated): March 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nootropic Agents; BI 425809
• Other Study ID Numbers: 1346.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency