A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225

Healthy Clinical Trial

Official title:

A Randomised, Single-blind, Placebo-controlled Trial in Parallel Group Design to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356225 Administered as Oral Solution and Tablets to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Bioavailability Comparison of BI 1356225 as Tablet With and Without Food

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065295
• Other study ID #: 1427-0001
• Secondary ID: 2019-000198-22
• Status: Completed
• Phase: Phase 1
• Start date: September 9, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: December 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objectives of the SRD part of this trial are to investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1356225 in healthy male subjects following oral administration of single rising doses. The main objective of the BA part of this trial will be to explore the influence of food on the bioavailability of tablet fasted versus tablet fed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 45 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

• 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

• Further exclusion criteria apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1356225
Oral Dose
• Placebo
Oral dose

Locations

Country	Name	City	State
Germany	Humanpharmakologisches Zentrum Biberach	Biberach

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint for assessment of safety and tolerability of BI 1356225 is the percentage of subjects with drug-related adverse events (both trial parts)		Up to 30 days
Secondary	AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)		Up to 30 days
Secondary	Cmax (maximum measured concentration of the analyte in plasma)		Up to 30 days

External Links

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