drugset / Trial / NCT01900171
Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo
RandomizedParallel-groupTriple-blind
Summary
QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.
Timeline
- Start
- 2012-02
- Primary completion
- 2012-05
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Firibastat | Small molecule | 10 mg | Oral |
| Subject | Firibastat | Small molecule | 50 mg | Oral |
| Subject | Firibastat | Small molecule | 125 mg | Oral |
| Subject | Firibastat | Small molecule | 250 mg | Oral |
| Subject | Firibastat | Small molecule | 500 mg | Oral |
| Subject | Firibastat | Small molecule | 750 mg | Oral |
| Subject | Firibastat | Small molecule | 1000 mg | Oral |
| Subject | Firibastat | Small molecule | 1250 mg | Oral |