NCT02362516

Brief Summary

To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 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

February 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

February 23, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2015

Completed
10.8 years until next milestone

Results Posted

Study results publicly available

March 30, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

February 9, 2015

Results QC Date

March 10, 2026

Last Update Submit

April 13, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14)

    Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14).

    0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.

  • Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14)

    Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14).

    1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.

  • Maximum Measured Concentration of BI 425809 in Plasma (Cmax)

    Maximum measured concentration of BI 425809 in plasma is reported. Time Frame: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809.

    10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description).

  • Maximum Measured Concentration of BI 425809 in CSF (Cmax)

    Maximum measured concentration of BI 425809 in CSF is reported.

    1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.

  • Concentration of BI 425809 in Plasma at the Time Point 312h (C312)

    Concentration of BI 425809 in plasma at the time point 312h (C312) is reported.

    0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809.

  • Concentration of BI 425809 in CSF at the Time Point 312h (C312)

    Concentration of BI 425809 in CSF at the time point 312h (C312) is reported.

    1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.

Secondary Outcomes (1)

  • Percentage of Participants With Drug-related Adverse Events (AEs)

    From the first drug administration until 11 days after the last drug administration, up to 30days.

Study Arms (4)

BI 425809 5 mg

EXPERIMENTAL

Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.

Drug: BI 425809

BI 425809 10 mg

EXPERIMENTAL

Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.

Drug: BI 425809

BI 425809 25 mg

EXPERIMENTAL

Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.

Drug: BI 425809

BI 425809 50 mg

EXPERIMENTAL

Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.

Drug: BI 425809

Interventions

BI 425809DRUG

Tablet

Also known as: Iclepertin
BI 425809 10 mgBI 425809 25 mgBI 425809 5 mgBI 425809 50 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
  • Age of 18 to 55 years (incl.)
  • Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
  • Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation

You may not qualify if:

  • Any finding in the medical examination (including blood pressure (BP), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range and considered as clinical relevant by investigator
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged as 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1346.3.32001 Boehringer Ingelheim Investigational Site

Antwerp, Belgium

Location

Related Links

MeSH Terms

Interventions

BI 425809

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 13, 2015

Study Start

February 23, 2015

Primary Completion

June 19, 2015

Study Completion

June 19, 2015

Last Updated

May 1, 2026

Results First Posted

March 30, 2026

Record last verified: 2026-04

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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Locations

BE(1)