Healthy, Metabolic Dysfunction-associated Steatohepatitis
Conditions
Brief summary
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.
Interventions
DRUGBI 3804379
BI 3804379
DRUGPlacebo matching BI 3804379
Placebo matching BI 3804379
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
for Part A and Part B: 1. 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 2. Age of 18 to 65 years (inclusive) 3. Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive) 4. 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 Inclusion criteria for Part C: 1\. Male or female patients with advanced liver fibrosis due to MASH, aged between 18 and 70 years (inclusive) Further inclusion criteria apply
Exclusion criteria
for Part A and Part B: 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator. 2. 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). 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. 4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance. Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A, Part B and Part C: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator | Up to Day 84 for Part A and up to Day 235 for Part B and Part C. |
Secondary
| Measure | Time frame |
|---|---|
| Part A: AUC0-∞ (area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity) | Up to Day 84. |
| Part A: Cmax (maximum measured concentration of the analyte in serum) | Up to Day 84. |
| 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) | Up to Day 235. |
| Part B and Part C: Cmax,ss (maximum measured concentration of the analyte in serum at steady state over a uniform dosing interval τ) | Up to Day 235. |
Countries
Belgium
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed