Phase 1
Completed N=22
Drug Interaction Study With Rifampicin and Afatinib
Healthy
Source: ClinicalTrials.gov NCT01396265 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Area Under Curve From 0 to Infinity Hours (AUC0-∞) — 912; 610 ng*h/mL
Summary
The objective of the current study is to investigate the effect of the P-gp inducer rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under Curve From 0 to Infinity Hours (AUC0-∞) |
912; 610 | — |
| PRIMARY Area Under Curve From 0 to tz (AUC0-tz) |
860; 575 | — |
| PRIMARY Maximum Concentration (Cmax) |
38.3; 30.0 | — |
| SECONDARY Time From Dosing to the Maximum Concentration of Afatinib in Plasma (Tmax) |
6.00; 6.00 | — |
| SECONDARY Terminal Half-life of Afatinib in Plasma (t1/2) |
32.8; 36.0 | — |
| SECONDARY Area Under Curve From 0 to 24 h (AUC0-24) |
491; 353 | — |
| SECONDARY Percentage of the AUCtz-∞ Obtained by Extrapolation (%AUCtz-∞) |
5.25; 5.48 | — |
| SECONDARY Mean Residence Time of Afatinib in the Body After Oral Administration (MRTpo) |
36.9; 35.1 | — |
| SECONDARY Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F) |
731; 1090 | — |
| SECONDARY Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F) |
2080; 3410 | — |
Eligibility Criteria
Inclusion criteria
Healthy male volunteers
Exclusion criteria
Any relevant deviations from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01396265). 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.