Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ritonavir + afatinib; Drug: afatinib

• Registration Number: NCT01426958
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Primary Completion: 2011-12
• Results First Submitted: 2013-08-08
• Status Verified: 2013-10
• Results First Submitted QC: 2013-10-29
• Results First Posted: 2013-12-19
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
treatment C	ritonavir + afatinib	2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
treatment A	afatinib	1 tablet afatinib single dose
treatment B	ritonavir + afatinib	2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day

Primary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax)	0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post	Cmax represents the maximum concentration of the analyte in plasma.
Area Under Curve From 0 to tz (AUC0-tz)	0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post	AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte.
Area Under Curve From 0 to ∞ Hours (AUC0-∞)	0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post	AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.

Trial Locations

Locations (1)

1200.151.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany