drugset / Trial / NCT02182258
Safety and Tolerability Study of BIBF 1120 as Intravenous Infusion and Absolute Bioavailability of BIBF 1120 as Soft Gelatine Capsule in Healthy Subjects
Non-randomizedParallel-groupSingle-blindTreatment
Summary
The primary objective of this trial was to assess the safety and tolerability of BIBF 1120 administered as intravenous (iv) infusions of 1, 3, 10, and 20 mg, and to assess the absolute bioavailability of orally administered 100 mg BIBF 1120 as soft gelatine capsules. A secondary objective was the exploration of the pharmacokinetic (PK) of BIBF 1120 after single iv dosing, including dose proportionality.
Timeline
- Start
- 2009-06
- Primary completion
- 2009-08
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nintedanib | Small molecule | 1 mg | Intravenous |
| Comparator | Nintedanib | Small molecule | 3 mg | Intravenous |
| Comparator | Nintedanib | Small molecule | 10 mg | Intravenous |
| Comparator | Nintedanib | Small molecule | 20 mg | Intravenous |
| Comparator | Nintedanib | Small molecule | 100 mg | Intravenous |
Indications
No indication recorded.