A Study in Healthy Men to Test How Well Multiple Doses of BI 1839100 Are Tolerated and How BI 1839100 Influences the Amount of Other Medicines in the Blood

NCT05738291 | Completed Phase 1

• 2 other identifiers: 1490-00022022-003161-38
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Effects of multiple rising doses of BI 1839100 on safety, tolerability, pharmacokinetics and the effect of high-fat meal on pharmacokinetics of BI 1839100 will be assessed as well as assessing potential drug-drug interactions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• MRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

  Multiple-rising dose (MRD)

  up to 26 days

• DDI part: Area under the concentration-time curve of midazolam, digoxin and rosuvastatin when administered without BI 1839100 over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  Drug-Drug Interaction (DDI)

  up to 20 days

• DDI part: Maximum measured concentration of midazolam, digoxin and rosuvastatin when administered without BI 1839100 in plasma (Cmax)

  up to 20 days

• DDI part: Area under the concentration-time curve of midazolam, digoxin and rosuvastatin when co-administered with BI 1839100 over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  up to 7 days

• DDI part: Maximum measured concentration of midazolam, digoxin and rosuvastatin when co-administered with BI 1839100 in plasma (Cmax)

  up to 7 days

Secondary Outcomes (6)

• MRD part: Maximum measured concentration of the analyte in plasma after single dose (Cmax)

  at Day 1

• MRD part: Time from dosing to maximum measured concentration of the analyte in plasma (tmax)

  at Day 1

• MRD part: Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 12 hours (AUC0-12)

  at Day 1

• MRD part: Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 48 hours (AUC0-48)

  up to 48 hours

• MRD part: Area under the concentration-time curve of the analyte in plasma over a uniform 12 hours dosing interval (τ) [after Nth dose] (AUCτ( ,N))

  up to 17 days

Study Arms (7)

MRD part: BI 1839100 dose group 1

EXPERIMENTAL

Multiple rising dose (MRD)

Drug: BI 1839100

MRD part: BI 1839100 dose group 2

EXPERIMENTAL

Multiple rising dose (MRD)

Drug: BI 1839100

MRD part: BI 1839100 dose group 3

EXPERIMENTAL

Multiple rising dose (MRD)

Drug: BI 1839100

MRD part: BI 1839100 dose group 4

EXPERIMENTAL

Multiple rising dose (MRD)

Drug: BI 1839100

MRD part: BI 1839100 dose group 5

EXPERIMENTAL

Multiple rising dose (MRD)

Drug: BI 1839100

MRD part: Placebo matching BI 1839100

PLACEBO COMPARATOR

Drug: Placebo matching BI 1839100

DDI part

EXPERIMENTAL

Drug-Drug Interaction (DDI)

Drug: BI 1839100; Drug: midazolam; Drug: digoxin; Drug: rosuvastatin

Interventions

BI 1839100 DRUG

BI 1839100

DDI part; MRD part: BI 1839100 dose group 1; MRD part: BI 1839100 dose group 2; MRD part: BI 1839100 dose group 3; MRD part: BI 1839100 dose group 4; MRD part: BI 1839100 dose group 5

Placebo matching BI 1839100 DRUG

Placebo matching BI 1839100

MRD part: Placebo matching BI 1839100

midazolam DRUG

midazolam

DDI part

digoxin DRUG

digoxin

DDI part

rosuvastatin DRUG

rosuvastatin

DDI part

Eligibility Criteria

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

You may qualify if:

• Physically and mentally 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 31.9 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 millimetre(s) of mercury (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) (subjects with heart rate values between 45 and 50 bpm may only be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
• 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 assessed as clinically relevant by the investigator
• 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 assessed as clinically relevant by the investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

ICON-Groningen-62040

Groningen, 9728 NZ, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Interventions

Midazolam; Digoxin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: MRD: single blinded to subject DDI: open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The multiple-rising dose (MRD) part of this trial is designed as single blinded to subject, randomised, and placebo-controlled within parallel dose groups. The Drug-Drug Interaction (DDI) part of this trial is designed as open-label, within-group comparison interaction trial.

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: May 1, 2023
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)