Phase 1
Completed N=34
Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers
Healthy
Source: ClinicalTrials.gov NCT01679613 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞) — 38.6; 61.3 ng*h/mL — p=1.0000
Summary
The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞) |
38.6; 61.3 | 1.0000 |
| PRIMARY Maximum Measured Concentration (Cmax) |
4.19; 7.13 | 1.0000 |
| SECONDARY Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz) |
35.7; 59.4 | 1.000 |
Eligibility Criteria
Inclusion criteria
- healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01679613). 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.