CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
BI 1467335 (Treatment A) +2 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Healthy male subjects aged 18 to 55 years
  • ✓BMI 18.5 to 29.9 kg/m²
  • ✓Normal medical history, physical exam, vital signs, ECG, and clinical lab tests
  • ✓Signed informed consent
Key exclusion· 21
  • ✕Any clinically relevant abnormality on physical exam, vital signs, or ECG
  • ✕Systolic BP outside 90–140 mmHg, diastolic BP outside 50–90 mmHg, or pulse rate outside 50–90 bpm on repeated measurement
  • ✕Any clinically relevant laboratory abnormality
  • ✕Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders

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

Search/NCT02999191
NCT02999191Phase 1Completed
CompareCT.gov

Relative Bioavailability of a BI 1467335 Tablet Compared to a BI 1467335 Oral Solution and the Effect of Food on the Bioavailability of the Tablet Following Oral Administration (a Randomised, Open-label, Single Dose, Three-way Crossover Trial in Healthy Male Subjects)

Boehringer Ingelheim·interventional·Posted Dec 21, 2016·Updated Jun 7, 2021

In Brief

A Phase 1 clinical trial evaluating BI 1467335 (Treatment A), BI 1467335 (Treatment B), and 1 other intervention for Healthy Volunteers. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The primary objective of this trial is to investigate the relative bioavailability of BI 1467335, given as film-coated tablet compared to BI 1467335, given as oral solution. This assessment will be performed under fasted conditions. Furthermore, the effect of food on relative bioavailability of the tablet formulation of BI 1467335 will be investigated.

Study Details

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

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 21, 2016
Enrollment StartJan 10, 2017
Primary CompletionMar 15, 2017
Study CompletionApr 10, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.5 years ago

Interventions

BI 1467335 (Treatment A)drug

BI 1467335 (Treatment B)drug

BI 1467335 (Treatment C)drug