Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: afatinib; Drug: ritonavir + afatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01426958

2011-001803-11 (EudraCT Number)

1200.151

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. healthy male subjects

Exclusion criteria

1. any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

treatment A

Active Comparator group

Description:

1 tablet afatinib single dose

Treatment:

Drug: afatinib

treatment B

Experimental group

Description:

2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day

Treatment:

Drug: ritonavir + afatinib

Drug: ritonavir + afatinib

treatment C

Experimental group

Description:

2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day

Treatment:

Drug: ritonavir + afatinib

Drug: ritonavir + afatinib