drugset / Trial / NCT03230487
This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body
RandomizedParallel-groupSingle-blindTreatment
Summary
Part 1 (SRD (Single-rising dose)): The primary objective of this trial part is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single dosing. Part 2 (MRD (Multiple-rising dose)): In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple dosing.
Timeline
- Start
- 2017-08-10
- Primary completion
- 2018-01-16
- Completion
- 2018-01-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nerandomilast | Small molecule | 6 mg | Oral |
| Subject | Nerandomilast | Small molecule | 12 mg | Oral |
| Subject | Nerandomilast | Small molecule | 36 mg | Oral |
| Subject | Nerandomilast | Small molecule | 48 mg | Oral |
Indications
No indication recorded.