Healthy
Conditions
Brief summary
Single-rising dose (SRD) part: The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3009947 in healthy participants following oral administration of single rising doses. Bioavailability (BA) part: The main objective of the BA part is to investigate the relative bioavailability of two different BI 3009947 formulations (Formulation A and B) and to assess the influence of food on the relative bioavailability of Formulation A or B.
Interventions
DRUGBI 3009947 (Formulation A)
BI 3009947 (Formulation A)
DRUGBI 3009947 (Formulation B)
BI 3009947 (Formulation B)
DRUGPlacebo
Placebo matching BI 3009947 (Formulation A)
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
SRD part: participants masked, single blind BA part: no masking, open label
Intervention model description
SRD part: placebo-controlled BA part: three-way crossover trial with 3 treatment periods to compare the relative bioavailability of reference treatment R and test treatments T1 and T2
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male trial participant 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 2. Age of 18 to 45 years (inclusive) 3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive) 4. 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
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 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 50 to 90 bpm 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin) 5. Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator | up to Day 14 | This is expressed as the percentage of subjects treated with investigational drug who experience such an event. |
| BA part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours) | up to Day 3 | — |
| BA part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours) | up to Day 3 | — |
| BA part: Cmax (maximum measured concentration of BI 3009947 in plasma) | up to Day 3 | — |
| BA part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma) | up to Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| SRD part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours) | up to Day 3 |
| SRD part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours) | up to Day 3 |
| SRD part: Cmax (maximum measured concentration of BI 3009947 in plasma) | up to Day 3 |
| SRD part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma) | up to Day 3 |
| BA part: AUC0-∞ (area under the concentration-time curve of BI 3009947 in plasma over the time interval from 0 extrapolated to infinity) | up to Day 3 |
| BA part: AUC0-∞ (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the time interval from 0 extrapolated to infinity) | up to Day 3 |
Countries
Germany
Outcome results
None listed