- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02182349
Metabolism and Pharmacokinetics of Oral Solution of [14C]-BI 201335 in Healthy Male Volunteers
July 17, 2014 updated by: Boehringer Ingelheim
Metabolism and Pharmacokinetics of a Single Dose of 240 mg [14C]-BI 201335 Given as Oral Solution to Healthy Male Volunteers at Steady State of BI 201335 NA Maintained With Oral Capsules of 240 mg BI 201335, a Phase I, Single-arm, Open-label Trial
Study to determine the pharmacokinetics (PK) of BI 201335 and total radioactivity including excretion mass balance, excretion pathways and metabolism following the oral administration of [14C]-BI 201335 at steady state.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
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
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy males according to a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG (electrocardiogram), and clinical laboratory tests
- Age 18 to 55 years, inclusive
- Body mass index 18.5 to 29.9 kg/m2, inclusive
- Nonsmoker
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Exclusion Criteria:
- Any finding in the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal, psychiatric or neurological disorders (including all forms of epilepsy)
- Surgery of the gastrointestinal tract (except appendectomy)
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Subjects with Gilbert's Syndrome
- 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 one month prior to administration of the trial drug
- Use of prescription medication, over-the-counter drugs or herbal preparations within 14 days prior to administration of the trial drug
- Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
- History or evidence of habitual tobacco or nicotine use within six months prior to administration of the trial drug
- Alcohol abuse (more than 2 ounces of alcohol/day)
- Drug abuse in opinion of investigator
- Blood donation (more than 100 mL within four weeks prior to administration of trial drug or during the trial)
- Excessive physical activity within five days prior to administration of trial drug
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial centre
- marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- Male subjects must agree to minimise the risk of female partners becoming pregnant from the dosing day until three months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than three months prior to dosing, barrier contraception, or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intrauterine device, tubal ligation, hormonal contraceptive for at least two months, or diaphragm with spermicide
- Participation in more than one other radiolabelled investigational drug trial within one year prior to administration of the trial drug. The previous radiolabelled trial drug must have been received more than six months prior to administration of the trial drug for this study, and the total exposure from this study and the previous study will be within the recommended levels considered safe (e.g., less than 5000 mrem whole body annual exposure)
- Irregular defecation pattern (less than one bowel movement a day)
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 201335 NA
multiple doses of BI 201335 NA soft gelatin capsule on days 1-8 and 11-15 and one single dose of [14C]-BI 201335 NA radiolabelled drug on day 9
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Individual concentration-time profiles of [14C]-radioactivity in whole blood, plasma, saliva, urine, and faeces
Time Frame: up to 28 days
|
up to 28 days
|
Individual concentration-time profiles of BI 201335 ZW in plasma and urine
Time Frame: up to 28 days
|
up to 28 days
|
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time Frame: up to 28 days
|
up to 28 days
|
Elucidation of metabolite structures and identification of major metabolites in urine, faeces, and plasma in comparison with various animal species
Time Frame: up to 28 days
|
up to 28 days
|
Cblood cell/Cplasma ratio of [14C]-radioactivity
Time Frame: up to 28 days
|
up to 28 days
|
Measurement of the plasma protein binding of total [14C]-radioactivity in human plasma samples ex vivo
Time Frame: up to day 28
|
up to day 28
|
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time Frame: up to day 28
|
up to day 28
|
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Time Frame: up to day 28
|
up to day 28
|
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time Frame: up to day 28
|
up to day 28
|
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time Frame: up to day 28
|
up to day 28
|
λz,ss (terminal rate constant of the analyte in plasma at steady state)
Time Frame: up to day 28
|
up to day 28
|
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time Frame: up to day 28
|
up to day 28
|
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time Frame: up to day 28
|
up to day 28
|
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following multiple oral dose administration)
Time Frame: up to day 28
|
up to day 28
|
Vz/F,ss (apparent volume of distribution of the analyte during the terminal phase λz at steady state following oral administration)
Time Frame: up to day 28
|
up to day 28
|
Ae,urine,0-tz,ss (amount of analyte that is eliminated in urine at steady state from the time point 0 to time point tz)
Time Frame: up to day 28
|
up to day 28
|
fe,urine,t1-t2,ss (fraction of the analyte in % of dose that is eliminated in urine at steady state from the time point 0 to time point tz)
Time Frame: up to day 28
|
up to day 28
|
Ae,feces,t1-t2,ss (fraction of the analyte that is eliminated in faeces at steady state from time point 0 to time point tz)
Time Frame: up to day 28
|
up to day 28
|
fe,feces,0-tz,ss (fraction of the analyte eliminated in faeces at steady state from time point 0 to time point tz)
Time Frame: up to day 28
|
up to day 28
|
CLR,t1-t2,ss (renal clearance of the analyte at steady state from the time point 0 to time point tz)
Time Frame: up to day 28
|
up to day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with abnormal findings in physical examination
Time Frame: Baseline and day 28
|
Baseline and day 28
|
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Time Frame: Baseline, day 1, 10, 16 and 28
|
Baseline, day 1, 10, 16 and 28
|
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time Frame: Baseline, day 1, 10, 16 and 28
|
Baseline, day 1, 10, 16 and 28
|
Number of patients with clinically significant changes in clinical laboratory tests (haematology, clinical chemistry, urinalysis)
Time Frame: Baseline, day 10 and 28
|
Baseline, day 10 and 28
|
Number of patients with adverse events
Time Frame: up to 28 days
|
up to 28 days
|
Assessment of tolerability on a 4-point scale by the investigator
Time Frame: Day 28
|
Day 28
|
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
June 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
July 2, 2014
First Submitted That Met QC Criteria
July 2, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 17, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 1220.33
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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