Drug Interaction Study With Rifampicin and Afatinib

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Rifampicin; Drug: Afatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396265

2011-001804-37 (EudraCT Number)

1200.152

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy male volunteers

Exclusion criteria

Any relevant deviations from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Afatinib alone (Reference)

Experimental group

Description:

Tablet, Oral administration with 240 mL of water

Treatment:

Drug: Afatinib

Drug: Afatinib

Rifampicin + Afatinib (Test)

Experimental group

Description:

Tablet, Oral administration with 240 mL of water

Treatment:

Drug: Afatinib

Drug: Rifampicin

Drug: Afatinib