Phase 1
Completed N=24
Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT01426958 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Area Under Curve From 0 to tz (AUC0-tz) — 392; 478; 438 ng*h/mL — p=0.1009
Summary
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under Curve From 0 to tz (AUC0-tz) |
392; 478; 438 | 0.1009 |
| PRIMARY Maximum Concentration (Cmax) |
19.5; 20.7; 20.7 | 0.0002 sig |
| PRIMARY Area Under Curve From 0 to ∞ Hours (AUC0-∞) |
426; 515; 475 | 0.0702 |
Eligibility Criteria
Inclusion criteria
- healthy male subjects
Exclusion criteria
- any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01426958). 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.