drugset / Trial / NCT02595203
Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects
Non-randomizedParallel-groupOpen-labelBasic science
Summary
The primary objectives of this study are: * To determine the mass balance recovery (expired air, urine and faeces) and route and rate of elimination of 14C-Debio 1450. * To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and faeces. * To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug) and Debio 1452 (active moiety) in plasma and urine.
Timeline
- Start
- 2015-11
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afabicin | Small molecule | 0.037 mbq | Intravenous |
| Subject | Afabicin | Small molecule | 3.7 mbq | Intravenous |
| Subject | Afabicin | Small molecule | 240 mg | Intravenous |
Indications
No indication recorded.