Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

Boehringer Ingelheim24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

afatinibDRUG

standard therapeutic dose

ritonavir + afatinibDRUG

simultaneous intake of ritonavir and afatinib on second treatment day

ritonavir + afatinibDRUG

on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1\. healthy male subjects Exclusion criteria: 1\. any relevant deviation from healthy conditions

Locations (1)

1200.151.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Outcomes

Primary Outcomes

Area Under Curve From 0 to tz (AUC0-tz)

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.

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post

Maximum Concentration (Cmax)

Cmax represents the maximum concentration of the analyte in plasma.

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post

Area Under Curve From 0 to ∞ Hours (AUC0-∞)

AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post

Data from ClinicalTrials.gov

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