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A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People and Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH)

ConditionsHealthyMetabolic Dysfunction-associated Steatohepatitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBoehringer Ingelheim

About this trial

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female participants and in stable patients with advanced liver fibrosis due to MASH following administration of single rising doses and administration of multiple rising doses.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male or female (of non-child-bearing potential) participants 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), respiratory rate (RR), temperature (TEMP)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

Age of 18 to 65 years (inclusive)

Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive)

Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply

Disqualifiers

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 BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm).

Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.

Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BI 3804379

    Drug

    BI 3804379

  • Placebo matching BI 3804379

    Drug

    Placebo matching BI 3804379

Treatment groups

124 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A (SRD): BI 3804379Experimental treatment 1 intervention
Group B: Part A (SRD): Placebo matching BI 3804379Placebo comparator 1 intervention
Group C: Part B (MRD): BI 3804379Experimental treatment 1 intervention
Group D: Part B (MRD): Placebo matching BI 3804379Placebo comparator 1 intervention
Group E: Part C (MASH MRD): BI 3804379Experimental treatment 1 intervention
Group F: Part C (MASH MRD): Placebo matching BI 3804379Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part A, Part B and Part C: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator

Time frame
Up to Day 84 for Part A and up to Day 235 for Part B and Part C.

Secondary outcomes

1

Part A: AUC0-∞ (area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity)

Time frame
Up to Day 84.
2

Part A: Cmax (maximum measured concentration of the analyte in serum)

Time frame
Up to Day 84.
3

Part B and Part C: AUCτ,ss (area under the concentration-time curve of the analyte in serum at steady state over a uniform dosing interval τ)

Time frame
Up to Day 235.
4

Part B and Part C: Cmax,ss (maximum measured concentration of the analyte in serum at steady state over a uniform dosing interval τ)

Time frame
Up to Day 235.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boehringer Ingelheim

Lead sponsor

Source ClinicalTrials.gov
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