Drug Interaction Study With Rifampicin and Afatinib

NCT01396265 | Completed Phase 1 Results

• 2 other identifiers: 1200.1522011-001804-37
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area Under Curve From 0 to Infinity Hours (AUC0-∞)

  AUC0-∞ represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.

  0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose

• Area Under Curve From 0 to tz (AUC0-tz)

  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.

  0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose

• Maximum Concentration (Cmax)

  Cmax represents the maximum concentration of the analyte in plasma.

  0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose

Secondary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Afatinib alone (Reference)

EXPERIMENTAL

Tablet, Oral administration with 240 mL of water

Drug: Afatinib

Rifampicin + Afatinib (Test)

EXPERIMENTAL

Tablet, Oral administration with 240 mL of water

Drug: Afatinib; Drug: Rifampicin

Interventions

Afatinib DRUG

single dose

Afatinib alone (Reference)

Rifampicin DRUG

multiple doses

Rifampicin + Afatinib (Test)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers

You may not qualify if:

• Any relevant deviations from healthy conditions

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1200.152.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

Afatinib; Rifampin

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 18, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Last Updated: June 9, 2014
• Results First Posted: December 9, 2013

Record last verified: 2013-10

Locations

DE (1)