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Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Age of 18 to 50 years (inclusive)
  • BMI of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
  • 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
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • 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
  • History of relevant orthostatic hypotension, fainting spells, or blackouts -Further exclusion criteria apply

Treatment and study plan

BI 1819479

Drug

BI 1819479

Placebo

Drug

Placebo

Primary outcomes

  1. Percentage of subjects with drug-related adverse events

    Time frame: Up to Day 36

    Single rising doses (SRD) part

  2. 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)

    Time frame: Up to Day 31

    Food effect part

  3. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to Day 31

    Food effect part

Secondary outcomes

  1. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to Day 31

    SRD part

  2. 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)

    Time frame: Up to Day 31

    SRD part

  3. Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: Up to Day 31

    Food effect part

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2021
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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