Phase 1
Completed N=26
Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin
Healthy
Source: ClinicalTrials.gov NCT01770392 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞) — 183; 89.4 ng*h/mL — p=1.0000
Summary
To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of nintedanib
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞) |
183; 89.4 | 1.0000 |
| PRIMARY Maximum Measured Concentration (Cmax) |
22.1; 12.8 | 1.0000 |
| SECONDARY Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz) |
173; 84.1 | 1.0000 |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01770392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.