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Drug Interaction Study With Rifampicin and Afatinib

NCT ID: NCT01396265

Last Updated: 2014-06-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Afatinib alone (Reference)

Tablet, Oral administration with 240 mL of water

Group Type EXPERIMENTAL

Afatinib

Intervention Type DRUG

single dose

Rifampicin + Afatinib (Test)

Tablet, Oral administration with 240 mL of water

Group Type EXPERIMENTAL

Afatinib

Intervention Type DRUG

single dose

Rifampicin

Intervention Type DRUG

multiple doses

Interventions

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Afatinib

single dose

Intervention Type DRUG

Afatinib

single dose

Intervention Type DRUG

Rifampicin

multiple doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Healthy male volunteers

Exclusion Criteria

Any relevant deviations from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1200.152.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-001804-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.152

Identifier Type: -

Identifier Source: org_study_id

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