NCT03817476

Brief Summary

The main objective of this trial is to investigate the relative bioavailability of batch 1 of the intended commercial tablet formulation (iCF1) of BI 425809 vs batch 2 of the intended commercial tablet formulation (iCF2) of BI 425809 vs BI 425809 (TF2) formulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Feb 2019

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

January 24, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2019

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

March 30, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

January 24, 2019

Results QC Date

March 10, 2026

Last Update Submit

April 7, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)

    Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 72 hours (AUC0-72). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'.

    within 3 hours before and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hours after drug administration.

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

    Cmax represents maximum measured concentration of BI 425809 in plasma. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'.

    within 3 hours before and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hours after drug administration.

Study Arms (6)

Treatment sequence A: TF2/iCF1/iCF2

EXPERIMENTAL

TF2(R):One 25 milligram (mg) BI 425809 TF2 tablet - iCF1(T1):One 25 mg BI 425809 iCF1 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments. TF=Tablet formulation, iCF=Intended commercial formulation.

Drug: iCF1(T1) 25 milligram BI 425809Drug: iCF2(T2) 25 milligram BI 425809Drug: TF2(R) 25 milligram BI 425809

Treatment sequence B: iCF1/iCF2/TF2

EXPERIMENTAL

iCF1(T1):One 25 milligram (mg) BI 425809 iCF1 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.

Drug: iCF1(T1) 25 milligram BI 425809Drug: iCF2(T2) 25 milligram BI 425809Drug: TF2(R) 25 milligram BI 425809

Treatment sequence C: iCF2/TF2/iCF1

EXPERIMENTAL

iCF2(T2):One 25 milligram (mg) BI 425809 iCF2 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet - iCF1(T1):One 25 mg BI 425809 iCF1 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.

Drug: iCF1(T1) 25 milligram BI 425809Drug: iCF2(T2) 25 milligram BI 425809Drug: TF2(R) 25 milligram BI 425809

Treatment sequence D: TF2/iCF2/iCF1

EXPERIMENTAL

TF2(R):One 25 milligram (mg) BI 425809 TF2 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet - iCF1(T1):One 25 mg BI 425809 iCF1 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.

Drug: iCF1(T1) 25 milligram BI 425809Drug: iCF2(T2) 25 milligram BI 425809Drug: TF2(R) 25 milligram BI 425809

Treatment sequence E: iCF1/TF2/iCF2

EXPERIMENTAL

iCF1(T1):One 25 milligram (mg) BI 425809 iCF1 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.

Drug: iCF1(T1) 25 milligram BI 425809Drug: iCF2(T2) 25 milligram BI 425809Drug: TF2(R) 25 milligram BI 425809

Treatment sequence F: iCF2/iCF1/TF2

EXPERIMENTAL

iCF2(T2):One 25 mg BI 425809 iCF2 tablet - iCF1(T1):One 25 milligram (mg) BI 425809 iCF1 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.

Drug: iCF1(T1) 25 milligram BI 425809Drug: iCF2(T2) 25 milligram BI 425809Drug: TF2(R) 25 milligram BI 425809

Interventions

iCF1(T1) 25 milligram BI 425809DRUG

One 25 milligram BI 425809 iCF1 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.

Also known as: Iclepertin
Treatment sequence A: TF2/iCF1/iCF2Treatment sequence B: iCF1/iCF2/TF2Treatment sequence C: iCF2/TF2/iCF1Treatment sequence D: TF2/iCF2/iCF1Treatment sequence E: iCF1/TF2/iCF2Treatment sequence F: iCF2/iCF1/TF2
iCF2(T2) 25 milligram BI 425809DRUG

One 25 milligram BI 425809 iCF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.

Also known as: Iclepertin
Treatment sequence A: TF2/iCF1/iCF2Treatment sequence B: iCF1/iCF2/TF2Treatment sequence C: iCF2/TF2/iCF1Treatment sequence D: TF2/iCF2/iCF1Treatment sequence E: iCF1/TF2/iCF2Treatment sequence F: iCF2/iCF1/TF2
TF2(R) 25 milligram BI 425809DRUG

One 25 milligram BI 425809 TF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.

Also known as: Iclepertin
Treatment sequence A: TF2/iCF1/iCF2Treatment sequence B: iCF1/iCF2/TF2Treatment sequence C: iCF2/TF2/iCF1Treatment sequence D: TF2/iCF2/iCF1Treatment sequence E: iCF1/TF2/iCF2Treatment sequence F: iCF2/iCF1/TF2

Eligibility Criteria

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

You may qualify if:

  • Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
  • Age of 18 to 55 years (inclusive)
  • Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
  • Male subjects, or female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
  • Use of adequate contraception, e.g. any of the following methods plus condom:
  • \--- implants, injectables, combined oral or vaginal contraceptives, intrauterine device
  • Sexually abstinent
  • A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
  • Surgically sterilised (including hysterectomy)
  • Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

You may not qualify if:

  • Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
  • Chronic or relevant acute infections
  • History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
  • Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
  • Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
  • 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 for females and 30 g per day for males)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 25, 2019

Study Start

February 11, 2019

Primary Completion

May 28, 2019

Study Completion

May 28, 2019

Last Updated

April 24, 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, except for the following exclusions: 1\. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

Locations

DE(1)