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CompletedNCT05738291Updated Nov 13, 2024

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

A Phase 1 interventional study of BI 1839100 and Placebo matching BI 1839100 in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-13.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    MRD part: BI 1839100 dose group 1

    Multiple rising dose (MRD)

    Drug: BI 1839100

  • Experimental
    MRD part: BI 1839100 dose group 2

    Multiple rising dose (MRD)

    Drug: BI 1839100

  • Experimental
    MRD part: BI 1839100 dose group 3

    Multiple rising dose (MRD)

    Drug: BI 1839100

  • Experimental
    MRD part: BI 1839100 dose group 4

    Multiple rising dose (MRD)

    Drug: BI 1839100

  • Experimental
    MRD part: BI 1839100 dose group 5

    Multiple rising dose (MRD)

    Drug: BI 1839100

  • Placebo comparator
    MRD part: Placebo matching BI 1839100

    Drug: Placebo matching BI 1839100

  • Experimental
    DDI part

    Drug-Drug Interaction (DDI)

    Drug: BI 1839100 · Drug: midazolam · Drug: digoxin · Drug: rosuvastatin

Interventions

  • DrugBI 1839100

    BI 1839100

  • DrugPlacebo matching BI 1839100

    Placebo matching BI 1839100

  • Drugmidazolam

    midazolam

  • Drugdigoxin

    digoxin

  • Drugrosuvastatin

    rosuvastatin

06

What researchers measure

Primary outcomes

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

    Multiple-rising dose (MRD)

    Time frame: up to 26 days

  2. 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)

    Time frame: up to 20 days

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

    Time frame: up to 20 days

  4. 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)

    Time frame: up to 7 days

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

    Time frame: up to 7 days

Secondary outcomes

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

    Time frame: at Day 1

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

    Time frame: at Day 1

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

    Time frame: at Day 1

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

    Time frame: up to 48 hours

  5. 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))

    Time frame: up to 17 days

  6. MRD part: Maximum measured concentration of the analyte in plasma [after Nth dose] (Cmax( ,N))

    Time frame: up to 17 days

07

Study locations

1 site
  • ICON-Groningen-62040
    Groningen, 9728 NZ, Netherlands
08

References and documents

Related links

Individual participant data

Plan to share: No — 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.mystudywindow.com/msw/datatransparency

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05738291
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Feb 22, 2023
Start date
May 1, 2023
Primary completion
Jun 14, 2024
Completion
Jun 14, 2024
Last update
Nov 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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