drugset / Trial / NCT04107805
A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated
RandomizedSequentialDouble-blindTreatment
Summary
The primary objective of this trial is to investigate the safety and tolerability of BI 1323495 in healthy subjects following bid oral administration of multiple rising doses, each over an 11 day treatment period. Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality (only for Part 1) as well as attainment of steady state. This includes exploration of a therapeutic exposure range, a range not adequately achieved in the single-rising dose trial 1405-0001.
Timeline
- Start
- 2019-11-04
- Primary completion
- 2021-03-05
- Completion
- 2021-03-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 1323495 | Unknown | 10 mg | Oral |
| Subject | BI 1323495 | Unknown | 30 mg | Oral |
| Subject | BI 1323495 | Unknown | 70 mg | Oral |
| Subject | BI 1323495 | Unknown | 120 mg | Oral |
| Subject | BI 1323495 | Unknown | 150 mg | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
Indications
No indication recorded.