Clinical trial NCT04801693: A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1819479 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1819479 (Open-label, Randomised, Two-way Crossover Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-03-17
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single rising dose part is single-blind, randomized, placebo-controlled within parallel dose groups.

food effect part is randomized, open-label, two-way, two-period, crossover design.
Primary purpose: TREATMENT

Brief summary: The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses.

The main objective of the food effect part is to investigate the influence of food on the relative bioavailability of BI 1819479.


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
2. Age of 18 to 50 years (inclusive)
3. BMI of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

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, in particular, hepatic parameters (ALT/AST) or renal parameters (creatinine) exceeding the ULN after repeated measurements
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts -Further exclusion criteria apply

Primary outcomes:
measure: Percentage of subjects with drug-related adverse events
timeFrame: Up to Day 36
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: Up to Day 31
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: Up to Day 31
Secondary outcomes:
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: Up to Day 31
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: Up to Day 31
measure: Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to Day 31
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: CRS Clinical Research Services Mannheim GmbH
Study officials:
References: