Drug Interaction Study With Rifampicin and Afatinib

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Afatinib; Drug: Rifampicin

• Registration Number: NCT01396265
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-15
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-18
• Primary Completion: 2011-08
• Results First Submitted: 2013-08-08
• Status Verified: 2013-10
• Results First Submitted QC: 2013-10-15
• Results First Posted: 2013-12-09
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Afatinib alone (Reference)	Afatinib	Tablet, Oral administration with 240 mL of water
Rifampicin + Afatinib (Test)	Afatinib	Tablet, Oral administration with 240 mL of water
Rifampicin + Afatinib (Test)	Rifampicin	Tablet, Oral administration with 240 mL of water

Primary Outcome Measures

Name	Time	Method
Area Under Curve From 0 to Infinity Hours (AUC0-∞)	0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose	AUC0-∞ represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Area Under Curve From 0 to tz (AUC0-tz)	0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose	AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.
Maximum Concentration (Cmax)	0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose	Cmax represents the maximum concentration of the analyte in plasma.

Secondary Outcome Measures

Name	Time	Method
Time From Dosing to the Maximum Concentration of Afatinib in Plasma (Tmax)	0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose	tmax represents the time from dosing to the maximum concentration of the analyte in plasma
Terminal Half-life of Afatinib in Plasma (t1/2)	0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose	t1/2 represents the terminal half-life of the analyte in plasma
Area Under Curve From 0 to 24 h (AUC0-24)	0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose	AUC0-24 represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours (h)
Percentage of the AUCtz-∞ Obtained by Extrapolation (%AUCtz-∞)	0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose	%AUCtz-∞ represents the percentage of the AUCtz-∞ obtained by extrapolation
Mean Residence Time of Afatinib in the Body After Oral Administration (MRTpo)	0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose	MRTpo represents the mean residence time of the analyte in the body after oral administration
Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F)	0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose	CL/F represents the apparent clearance of the analyte in the plasma after extravascular administration
Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F)	0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose	V_z/F represents the apparent volume of distribution during the terminal phase λz following an extravascular dose

Trial Locations

Locations (1)

1200.152.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany