A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 730357; Drug: BI 730357 mixed with [C-14] BI 730357 BS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03804671

1407-0033

2018-003103-19 (EudraCT Number)

Details and patient eligibility

About

To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared with [C-14]BI 730357 BS administered as intravenous microtracer

Enrollment: 6 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 65 years (inclusive)
• Body Mass Index (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 Good Clinical Practice (GCP) and local legislation
• Further inclusion criteria apply

Exclusion criteria

• Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the range of 40 to 100 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
• Clinically significant gastrointestinal (including known or suspected inflammatory bowel disease), hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

All Subjects

Experimental group

Description:

Test treatment T followed by Reference treatment R

Treatment:

Drug: BI 730357 mixed with [C-14] BI 730357 BS

Drug: BI 730357