drugset / Trial / NCT03483077
This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood.
RandomizedParallel-groupSingle-blindTreatment
Summary
The primary objective of the single-rising dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730460 in healthy subjects following oral administration of single rising doses. The secondary objective is the exploration of the pharmacokinetics (PK) including dose proportionality, and pharmacodynamics of BI 730460 after single dosing.
Timeline
- Start
- 2018-10-09
- Primary completion
- 2019-03-21
- Completion
- 2019-03-21
Outcome
Outcome not reported
Stopped: “The trial was ended after completion of dose group 6 of the SRD part, in accordance with a predefined protocol discontinuation criteria. The planned bioavailability evaluation was not performed due to the sponsor's decision.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 730460 | Unknown | 2 mg | Oral |
| Subject | BI 730460 | Unknown | 8 mg | Oral |
| Subject | BI 730460 | Unknown | 25 mg | Oral |
| Subject | BI 730460 | Unknown | 50 mg | Oral |
| Subject | BI 730460 | Unknown | 100 mg | Oral |
| Subject | BI 730460 | Unknown | 200 mg | Oral |
Indications
No indication recorded.