A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood

NCT05258110 | Completed Phase 1 Results

• 2 other identifiers: 1346-00352021-005585-17
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

In order to assess the potential impact of steady state BI 425809 on CYP3A clinically, the effect of BI 425809 on the midazolam pharmacokinetics will be evaluated. Midazolam is a recommended substrate of CYP3A4.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.

  Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809).

• Maximum Measured Concentration of Midazolam in Plasma (Cmax)

  Maximum measured concentration of midazolam in plasma (Cmax) is presented.

  Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809).

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809).

Study Arms (1)

midazolam alone (Reference (R)) / midazolam + iclepertin (BI 425809) (Test (T))

EXPERIMENTAL

All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). All participants were also orally administered one film-coated tablet of 10 mg iclepertin (BI 425809) once daily over 21 days (from Day -20 until Day 1 of Period 2) and 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). There was a washout phase of at least 24 hours between the administration of midazolam in Period 1 and the first iclepertin administration in Period 2. The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.

Drug: midazolam; Drug: iclepertin (BI 425809)

Interventions

midazolam DRUG

midazolam

Also known as: Midazolam-ratiopharm® 2 mg/ml solution

midazolam alone (Reference (R)) / midazolam + iclepertin (BI 425809) (Test (T))

iclepertin (BI 425809) DRUG

BI 425809

midazolam alone (Reference (R)) / midazolam + iclepertin (BI 425809) (Test (T))

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male 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 in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

You may not qualify if:

• Any finding in the medical examination (including BP, PR or 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 millimetre of mercury (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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Midazolam; Solutions; BI 425809

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Preparations

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
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: February 28, 2022
• Study Start: March 18, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)