Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02362516
• Date of registration: 09/02/2015
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809
• Scientific title: Non-randomised, Open Label, Sequential-group Study to Assess the Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 in Healthy Male Volunteers
• Date of first enrolment: February 2015
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02362516
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

- Healthy male according to the investigator's assessment, based on a complete medical
history including a physical examination, vital signs (blood pressure (BP), puls rate
(PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

- Age of 18 to 55 years (incl.)

- Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)

- Signed and dated written informed consent prior to admission to the study in
accordance with good clinical practice (GCP) and local legislation

Exclusion criteria:

- Any finding in the medical examination (including blood pressure (BP), puls rate (PR)
or electrocardiogram (ECG)) is deviating from normal and judged as clinically
relevant by the investigator

- Repeated measurement of systolic blood pressure outside the range and considered as
clinical relevant by investigator

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

- Any evidence of a concomitant disease judged as clinically relevant by the
investigator

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders

- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial
medication

- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders
Further exclusion criteria may apply



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: BI 425809

Primary Outcome(s)

AUC0-14 (area under the concentration-time curve of the analyte in plasma and CSF over the time interval from 0 to 14h) [Time Frame: 17 days]

C312 (concentration of the analyte in plasma and CSF at the time point 312h) [Time Frame: 17 days]

Cmax (maximum measured concentration of the analyte in plasma and CSF) [Time Frame: 17 days]

Secondary Outcome(s)

frequency [N(%)] of subjects with drug-related adverse events (AEs) [Time Frame: 30 days]

Secondary ID(s)

2014-005652-26

1346.3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors