- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183610
Investigation of the Metabolism and Pharmacokinetics of 10 mg [14C] BI 1356 Administered Orally Compared to 5 mg [14C] BI 1356 Administered Intravenously in Healthy Male Volunteers
July 7, 2014 updated by: Boehringer Ingelheim
Investigation of the Metabolism and Pharmacokinetics of 10 mg [14C] BI 1356 Administered Orally Compared to 5 mg [14C] BI 1356 Administered Intravenously in Healthy Male Volunteers in an Open Label, Single-dose and Parallel Study Design
To determine the basic pharmacokinetics of BI 1356 BS, its metabolite CD 1750 XX and radioactivity including excretion mass balance, excretion pathways and metabolism following the intravenous and oral administration of [14C] BI 1356 BS
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- Age >=30 and Age <=60 years
- BMI >=18.5 and BMI <=29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking during the stay in the trial centre
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
- Male subjects must agree to minimize the risk of female partners becoming pregnant from the dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide
Exclusion criteria specific for this study:
- Veins unsuitable for infusion and blood sampling
- PR interval >220 ms or QRS interval >120 ms
- Female gender
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: [14C] BI 1356 as oral (p.o.) solution
|
|
Experimental: [14C] BI 1356 solution for i.v. infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of individual time course profiles of [14C] radioactivity in whole blood, plasma, urine and faeces
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
Comparison of individual time course profiles of BI 1356 BS and its metabolite CD 1750 XX in plasma and urine
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time Frame: prior to and up to 120 h after start of administration
|
prior to and up to 120 h after start of administration
|
CBlood cell/Cplasma ratio of [14C] -radioactivity
Time Frame: 1:30, 3, 24 and 72 h after drug administration
|
1:30, 3, 24 and 72 h after drug administration
|
Measurement of the plasma protein binding of total [14C] radioactivity in human plasma samples ex vivo
Time Frame: 1:30 and 3 hours post drug administration
|
1:30 and 3 hours post drug administration
|
Cmax (maximum concentration of the analyte(s) in plasma)
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
AUC0-tz (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
AUC0-infinity (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to infinity)
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
λz (terminal rate constant in plasma)
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
t1/2 (terminal half-life of the analyte(s) in plasma)
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
MRTpo and MRT, respectively (mean residence time of the analyte(s) in the body after p.o. and i.v. administration)
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
CL/F (apparent/total clearance of the analyte(s) in plasma following extravascular and intravenous administration)
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular or intravenous administration (F=1) respectively)
Time Frame: before and up to 264 h after drug administration
|
before and up to 264 h after drug administration
|
feurine,0-tz (amount of analyte excreted in urine within the time interval zero to tz (=120 h) in % of dose)
Time Frame: prior to and up to 120 h after start of administration
|
prior to and up to 120 h after start of administration
|
fefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz (=120 h) in % of dose)
Time Frame: up to 120 h after drug administration
|
up to 120 h after drug administration
|
CLR,0-tz (renal clearance of analyte)
Time Frame: prior to and up to 120 h after start of administration
|
prior to and up to 120 h after start of administration
|
Fa (drug absorption based on radioactivity data)
Time Frame: up to 264 h after drug administration
|
up to 264 h after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: up to 47 days
|
up to 47 days
|
Global assessment of tolerability by investigator on a 4-point scale
Time Frame: on day 12 during ambulant visit or on day of discharge on day 13, 14 or 15
|
on day 12 during ambulant visit or on day of discharge on day 13, 14 or 15
|
Evaluation of local tolerability of the infusion by investigator on a 6-point scale
Time Frame: after start of infusion up to day 15
|
after start of infusion up to day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
July 7, 2014
First Submitted That Met QC Criteria
July 7, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 7, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1218.7
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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