CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
[14C]BI 1467335 +1 moredrug
Likely dose
[14C]BI 1467335 administered as oral solution once daily; BI 1467335 twice dailyAI-extracted
Key inclusion· 3
  • ✓Healthy male subjects aged 30 to 65 years
  • ✓BMI 18.5 to 29.9 kg/m²
  • ✓Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory tests
Key exclusion· 17
  • ✕Any clinically relevant abnormality in medical examination, vital signs, or ECG
  • ✕Any laboratory value outside reference range judged clinically relevant
  • ✕Clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • ✕History of CNS disease, seizures, stroke, or relevant neurological/psychiatric disorders

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03382509
NCT03382509Phase 1Completed
CompareCT.gov

A Phase I, Open-label, Single and Multiple Dose Trial to Investigate Metabolism and Pharmacokinetics of [14C]BI 1467335 Administered as Oral Solution in Healthy Male Volunteers

Boehringer Ingelheim·interventional·Posted Dec 26, 2017·Updated Jun 22, 2021

In Brief

A Phase 1 clinical trial evaluating [14C]BI 1467335 and BI 1467335 for Healthy. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Primary objective mass balance, excretion pathways and metabolism following a single oral dose of \[14C\]BI 1467335 given to healthy male subjects (a selected number of subjects will be treated with \[14C\]BI 1467335 after a preceding 27 days treatment with non-radiolabelled compound of BI 1467335 QD). Secondary objectives is to investigate the basic pharmacokinetics after single and multiple doses of BI 1467335 and its metabolites.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 26, 2017
Enrollment StartJan 12, 2018
Primary CompletionApr 19, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.5 years ago

Interventions

[14C]BI 1467335drug

Once Daily

BI 1467335drug

Twice Daily