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Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

NCT01426958 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-06-09

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

afatinib

standard therapeutic dose

DRUG

ritonavir + afatinib

simultaneous intake of ritonavir and afatinib on second treatment day

DRUG

ritonavir + afatinib

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01426958 on ClinicalTrials.gov