CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
BI 1467335 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 18 to 50 years (inclusive)
  • ✓Body mass index (BMI) 18.5 to 29.9 kg/m² (inclusive)
  • ✓Healthy status confirmed by complete medical history, physical examination, vital signs, BP, PR, 12-lead ECG, and clinical laboratory
  • ✓Female subjects must be surgically sterilized (including hysterectomy) or postmenopausal (≥1 year spontaneous amenorrhea)
Key exclusion· 16
  • ✕Any clinically relevant abnormality on medical examination, vital signs, BP, PR, 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 laboratory value outside the reference range considered clinically relevant by investigator
  • ✕Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders

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

Search/NCT02733627
NCT02733627Phase 1Completed
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1467335 in Healthy Male and Female Subjects (Double-blind, Randomised, Placebo-controlled Within Dose Groups)

Boehringer Ingelheim·interventional·Posted Apr 11, 2016·Updated Jun 7, 2021

In Brief

A Phase 1 clinical trial evaluating BI 1467335 and Placebo for Healthy. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1467335 in healthy male and female subjects following oral administration of multiple rising doses over 28 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and target engagement biomarkers of BI 1467335 after multiple dosing.

Study Details

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

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 11, 2016
Enrollment StartJul 7, 2016
Primary CompletionJul 12, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.2 years ago

Interventions

BI 1467335drug

Placebodrug