NCT02383888

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 11, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2015

Completed
10.7 years until next milestone

Results Posted

Study results publicly available

March 30, 2026

Completed
Last Updated

March 30, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

March 6, 2015

Results QC Date

March 10, 2026

Last Update Submit

March 10, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

    -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

    -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

    -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

    -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.

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

BI 425809 10 mg Tablet

EXPERIMENTAL

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

BI 425809 25 mg Tablet

EXPERIMENTAL

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

BI 425809 50 mg Tablet

EXPERIMENTAL

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

Interventions

PlaceboDRUG

Single dose matching BI 425809 administered as tablets orally with 240 mL of water after an overnight fast of at least 10 hours.

Placebo
BI 425809DRUG

Single dose administered orally as tablets with 240 mL water after an overnight fast of at least 10 hours

Also known as: Iclepertin
BI 425809 10 mg TabletBI 425809 25 mg TabletBI 425809 50 mg Tablet

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1346.4.82001 Boehringer Ingelheim Investigational Site

Busan, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31005336DERIVED

Related Links

MeSH Terms

Interventions

BI 425809

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 10, 2015

Study Start

May 11, 2015

Primary Completion

August 6, 2015

Study Completion

August 6, 2015

Last Updated

March 30, 2026

Results First Posted

March 30, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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

Locations

KR(1)