drugset / Trial / NCT03119077
Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAY1161116 | Unknown | — | Oral |
| Subject | Itraconazole | Small molecule | — | — |