Phase 1 N=6 Treatment

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT03804671 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized). — NA; NA mmol*h/L/kg

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: BI 730357 (Drug); BI 730357 mixed with [C-14] BI 730357 BS (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Boehringer Ingelheim
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized).	NA; NA	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03804671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.