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

NCT04801693 | Completed Phase 1

• 2 other identifiers: 1462-00012021-000208-39
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Percentage of subjects with drug-related adverse events

  Single rising doses (SRD) part

  Up to Day 36

• 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)

  Food effect part

  Up to Day 31

• Maximum measured concentration of the analyte in plasma (Cmax)

  Food effect part

  Up to Day 31

Secondary Outcomes (3)

• Maximum measured concentration of the analyte in plasma (Cmax)

  Up to Day 31

• 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)

  Up to Day 31

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

  Up to Day 31

Study Arms (4)

BI 1819479

EXPERIMENTAL

single rising doses (SRD) part

Drug: BI 1819479

Placebo

PLACEBO COMPARATOR

Single rising doses (SRD) part

Drug: Placebo

BI 1819479 fed - fasted arm

EXPERIMENTAL

Food effect part

Drug: BI 1819479

BI 1819479 fasted - fed arm

EXPERIMENTAL

Food effect part

Drug: BI 1819479

Interventions

BI 1819479 DRUG

BI 1819479

BI 1819479; BI 1819479 fasted - fed arm; BI 1819479 fed - fasted arm

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 17, 2021
• Study Start: May 26, 2021
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)