CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
BI 894416 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Healthy male subjects aged 18 to 50 years (inclusive)
  • ✓BMI 18.5 to 29.9 kg/m² (inclusive)
  • ✓Normal medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests
Key exclusion· 17
  • ✕Any clinically relevant abnormality in medical examination, vital signs, ECG, or neurological examination
  • ✕Systolic BP <90 or >140 mmHg, diastolic BP <50 or >90 mmHg, or pulse rate <45 or >90 bpm on repeated measurement
  • ✕Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • ✕History of seizures, stroke, or other relevant central nervous system, neurological, or psychiatric disorders

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

Search/NCT04060719
NCT04060719Phase 1Completed
CompareCT.gov

Effect of Rifampicin on the Pharmacokinetics of a Single Oral Dose of BI 894416 in Healthy Male Subjects (an Open-label, One-way Crossover Study)

Boehringer Ingelheim·interventional·Posted Aug 19, 2019·Updated Aug 14, 2023

In Brief

A Phase 1 clinical trial evaluating BI 894416 and Rifampicin for Healthy. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The main objective of this trial is to investigate the effect of rifampicin on the pharmacokinetics of BI 894416.

Study Details

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

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedAug 19, 2019
Enrollment StartSep 4, 2019
Primary CompletionOct 17, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.9 years ago

Interventions

BI 894416drug

tablet

Rifampicindrug

tablet