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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 730357; Drug: BI 730357 mixed with [C-14] BI 730357 BS

• Registration Number: NCT03804671
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-15
• Study Start: 2019-01-31
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Results First Submitted: 2022-08-12
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Results First Posted: 2023-07-25
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Subjects	BI 730357	Test treatment T followed by Reference treatment R
All Subjects	BI 730357 mixed with [C-14] BI 730357 BS	Test treatment T followed by Reference treatment R

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized).	Test treatment T: within 3h before and 1,1.5,2,2.5,3.5,5,7,12,24,72,120,168h after oral administration. Reference treatment R: within 3h before and 5,10,15,30,45 minutes and 1.25,2.25,3.75,5.75,10.75,22.75,70.75,118.75,166.75h after start of iv infusion.	Area under the concentration-time curve of the analyte over the time interval from 0 to infinity (AUC0-∞). For both arms results are presented in millimole (mmol) \* hours (h) / Litre (L) / kilogram (kg). This was achieved by transforming the reference arm to the treatment arm and normalizing the results according to the respective dose.

Trial Locations

Locations (1)

ICON; 🇳🇱 Groningen, Netherlands