HealthyPhase 1NCT01396265

Drug Interaction Study With Rifampicin and Afatinib

A Phase 1 study testing Afatinib and Rifampicin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Afatinib and Rifampicin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteGermany
Study dates: Jul 2011to Aug 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male volunteers

Who cannot join

Any relevant deviations from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1200.152.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone and After Multiple Doses of Rifampicin - an Open-label, Two-period, Fixed Sequence Clinical Phase I Trial in Healthy Male Volunteers

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
Being tested: Afatinib, Rifampicin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AfatinibDrug
single dose
AfatinibDrug
single dose
RifampicinDrug
multiple doses

Study groups in NCT01396265
Study group	Role	What they receive
Afatinib alone (Reference)	Experimental	Tablet, Oral administration with 240 mL of water Receives: Drug: Afatinib
Rifampicin + Afatinib (Test)	Experimental	Tablet, Oral administration with 240 mL of water Receives: Drug: Afatinib; Drug: Rifampicin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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)
tmax represents the time from dosing to the maximum concentration of the analyte in plasma
Measured: 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)
t1/2 represents the terminal half-life of the analyte in plasma
Measured: 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)
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)
Measured: 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-∞)
%AUCtz-∞ represents the percentage of the AUCtz-∞ obtained by extrapolation
Measured: 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)
MRTpo represents the mean residence time of the analyte in the body after oral administration
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F)
CL/F represents the apparent clearance of the analyte in the plasma after extravascular administration
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F)
V_z/F represents the apparent volume of distribution during the terminal phase λz following an extravascular dose
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Aug 2011

First posted18 Jul 2011 (estimated)
Study startJul 2011
Primary completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01396265
Sponsor's protocol ID: 1200.152
Other IDs: 2011-001804-37
Status last verified: Oct 2013
First submitted: 15 Jul 2011
Last updated: 9 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone and After Multiple Doses of Rifampicin - an Open-label, Two-period, Fixed Sequence Clinical Phase I Trial in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT01396265
Acronym / sponsor ID: 1200.152
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Aug 2011 (actual)
First posted: 18 Jul 2011 (estimated)
Results: Posted 9 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Afatinib alone (Reference)	Experimental	Drug: AfatinibTablet, Oral administration with 240 mL of water
Rifampicin + Afatinib (Test)	Experimental	Drug: Afatinib, Drug: RifampicinTablet, Oral administration with 240 mL of water

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy male volunteers

Key exclusion criteria (1 listed)

Any relevant deviations from healthy conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Afatinibsingle dose	Drug	Afatinib alone (Reference)
Afatinibsingle dose	Drug	Rifampicin + Afatinib (Test)
Rifampicinmultiple doses	Drug	Rifampicin + Afatinib (Test)

Primary outcome

Area Under Curve From 0 to Infinity Hours (AUC0-∞)
Time frame: 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)
Time frame: 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)
Time frame: 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.

7 secondary outcomes

Time From Dosing to the Maximum Concentration of Afatinib in Plasma (Tmax)
Time frame: 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)
Time frame: 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)
Time frame: 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-∞)
Time frame: 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)
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F)
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F)
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose

Results and safety

Results posted to the registry on 9 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Group	22	22

Primary outcome: Area Under Curve From 0 to Infinity Hours (AUC0-∞)

Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Afatinib n = 22	Afatinib + Rifa n = 21
Value	912 (38.3)	610 (32.1)

Afatinib vs Afatinib + Rifa: Geometric mean ratio: 66.20 (90% CI 60.815 to 72.057), ANOVA

Population analysed: PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.

Primary outcome: Area Under Curve From 0 to tz (AUC0-tz)

Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Afatinib n = 22	Afatinib + Rifa n = 21
Value	860 (39.8)	575 (32.3)

Afatinib vs Afatinib + Rifa: Geometric mean ratio: 66.18 (90% CI 60.656 to 72.213), ANOVA

Primary outcome: Maximum Concentration (Cmax)

Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Afatinib n = 22	Afatinib + Rifa n = 22
Value	38.3 (38.4)	30.0 (34.1)

Afatinib vs Afatinib + Rifa: Geometric mean ratio: 78.41 (90% CI 72.363 to 84.968), ANOVA

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: First administration of trial medication until 6 days after last administration of trial medication. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afatinib	0 of 22 (0%)	2 of 22 (9.1%)	Not reported
Afatinib + Rifa	0 of 22 (0%)	4 of 22 (18.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

Related trials for Healthy

RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Afatinib and Rifampicin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under Curve From 0 to Infinity Hours (AUC0-∞) (time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01396265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.