A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam

NCT06327256 | Completed Phase 1

• 3 other identifiers: 1509-00022023-509293-29-00U1111-1299-6907
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with drug-related adverse events

  Up to day 20

Secondary Outcomes (7)

• Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12)

  Up to 12 hours

• Maximum measured concentration BI 3000202 in plasma (Cmax)

  Up to 24 hours

• Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state

  Up to day 20

• Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state

  Up to day 20

• Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state

  Up to day 20

Study Arms (4)

Dose group 1

EXPERIMENTAL

Group receiving placebo or dose 1 of BI 3000202

Drug: BI 3000202; Drug: Placebo

Dose group 2

EXPERIMENTAL

Group receiving placebo or dose 2 of BI 3000202

Drug: BI 3000202; Drug: Placebo

Dose group 3

EXPERIMENTAL

Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo

Drug: BI 3000202; Drug: Placebo; Drug: Midazolam

Dose group 4

EXPERIMENTAL

Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo

Drug: BI 3000202; Drug: Placebo; Drug: Midazolam

Interventions

BI 3000202 DRUG

BI 3000202

Dose group 1; Dose group 2; Dose group 3; Dose group 4

Placebo DRUG

Placebo-matching BI 3000202

Dose group 1; Dose group 2; Dose group 3; Dose group 4

Midazolam DRUG

Midazolam

Dose group 3; Dose group 4

Eligibility Criteria

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

You may qualify if:

• Healthy male or female of non-childbearing potential 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/m\^2 (inclusive)
• Signed and dated written informed consent in accordance with International Conference of Harmonization-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 mmHg, or pulse rate outside the range of 45 to 90 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

• Related Info

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The multiple rising dose part of the trial will be blinded to the participants and investigators . The effect of midazolam will be assessed open label.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The multiple rising dose part of the trial will be conducted in a parallel group assignment. The effect of midazolam interaction will be assessed sequentially.

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: April 9, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)