drugset / Trial / NCT03119077

Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116

NCT03119077 ↗

Phase 1 Terminated 32 enrolled Bayer
RandomizedParallel-groupQuadruple-blindBasic science

Summary

This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.

Timeline

Start
2017-04-27
Primary completion
2017-09-08
Completion
2018-01-31

Outcome

Outcome not reported

Stopped: “Study early terminated due to lower drug exposure”

Drugs

EvaluationDrugModalityDoseRoute
Subject BAY1161116 Unknown — Oral
Subject Itraconazole Small molecule — —