CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
BI 894416drug
Likely dose
BI 894416 30 mg (3 tablets of 10 mg each) as a single oral dose with 240 mL waterAI-extracted
Key inclusion· 3
  • ✓Healthy male subjects aged 18 to 50 years (inclusive)
  • ✓BMI 18.5–29.9 kg/m²
  • ✓Complete medical history, physical exam, vital signs, 12-lead ECG, and clinical laboratory tests all within normal limits
Key exclusion· 22
  • ✕Any clinically relevant abnormality on physical exam, ECG, or lab testing
  • ✕Systolic BP outside 90–140 mmHg or diastolic BP outside 50–90 mmHg on repeated measurement, or pulse rate outside 45–90 bpm
  • ✕History of gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  • ✕Prior gastrointestinal surgery that could interfere with drug pharmacokinetics, except appendectomy or simple hernia repair

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

Search/NCT03871595
NCT03871595Phase 1Completed
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Relative Bioavailability of BI 894416 as Tablet Formulation Following a High-fat, High-calorie Breakfast Compared to Administration in the Fasting State in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

Boehringer Ingelheim·interventional·Posted Mar 12, 2019·Updated Aug 14, 2023

In Brief

A Phase 1 clinical trial evaluating BI 894416 for Healthy. Completed, enrolled 14 participants across 1 site.

Detailed Summary

Investigate the relative bioavailability of BI 894416 as tablet formulation following a high-fat, high calorie breakfast (Test, T) compared with administration in the fasting state (Reference, R)

Study Details

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

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMar 12, 2019
Enrollment StartMar 20, 2019
Primary CompletionApr 24, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.3 years ago

Interventions

BI 894416drug

3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water.