- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02172274
BI 10773 Administered as Oral Solution to Healthy Male Volunteers
June 20, 2014 updated by: Boehringer Ingelheim
A Phase I, Open-label, Single-dose Trial to Investigate the Metabolism and Pharmacokinetics of 50 mg [14C]-BI 10773 When Administered as Oral Solution to Healthy Male Volunteers
Study to determine the pharmacokinetics of BI 10773 and total radioactivity including excretion mass balance, excretion pathways and metabolism following the oral administration of [14C] BI 10773
Study Overview
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
Yes
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 60 g/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
- A marked baseline prolongation of QT/QTc interval (corrected QT 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 radiolabeled investigational drug trial within one year prior to administration of the trial drug. The previous radiolabeled 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, per 21 CFR (Code of Federal Regulations) 361.1 (eg, 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: [14C]-BI 10773 - oral solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax (maximum concentration of the analyte in plasma)
Time Frame: pre-dose and up to 144 hours after administration
|
pre-dose and up to 144 hours after administration
|
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time Frame: pre-dose and up to 144 hours after administration
|
pre-dose and up to 144 hours after administration
|
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time Frame: pre-dose and up to 144 hours after administration
|
pre-dose and up to 144 hours after administration
|
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity)
Time Frame: pre-dose and up to 144 hours after administration
|
pre-dose and up to 144 hours after administration
|
λz (terminal rate constant in plasma)
Time Frame: pre-dose and up to 144 hours after administration
|
pre-dose and up to 144 hours after administration
|
t1/2 (terminal half-life of the analyte(s) in plasma)
Time Frame: pre-dose and up to 144 hours after administration
|
pre-dose and up to 144 hours after administration
|
MRTpo (mean residence time of the analyte(s) in the body after oral administration)
Time Frame: pre-dose and up to 144 hours after administration
|
pre-dose and up to 144 hours after administration
|
CL/F (apparent/total clearance of the analyte(s) in plasma after an extravascular dose)
Time Frame: pre-dose and up to 144 hours after administration
|
pre-dose and up to 144 hours after administration
|
Vz/F (apparent volume of distribution during the terminal phase λz after an extravascular dose)
Time Frame: pre-dose and up to 144 hours after administration
|
pre-dose and up to 144 hours after administration
|
feurine,0-tz (amount of analyte excreted in urine over the time interval from 0 to the time of the last quantifiable data point in % of dose, additionally excretion within each sampling interval will be calculated)
Time Frame: pre-dose and up to 168 hours after administration
|
pre-dose and up to 168 hours after administration
|
fefaeces,0-tz (amount of analyte excreted in faeces over the time interval from 0 to the time of the last quantifiable data point in % of dose, additionally excretion within each sampling interval will be calculated)
Time Frame: pre-dose and up to 168 hours after administration
|
pre-dose and up to 168 hours after administration
|
CLR,0-tz (renal clearance of analyte)
Time Frame: pre-dose and up to 168 hours after administration
|
pre-dose and up to 168 hours after administration
|
Individual concentration-time profiles of [14C] radioactivity in whole blood, plasma, urine, and faeces
Time Frame: up to 8 days
|
up to 8 days
|
Individual concentration-time profiles of BI 10773 in plasma and urine
Time Frame: up to 8 days
|
up to 8 days
|
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time Frame: up to 8 days
|
up to 8 days
|
Identification of major metabolites in urine, faeces, and plasma
Time Frame: up to 8 days
|
up to 8 days
|
Cblood cell/Cplasma ratio of [14C]-radioactivity
Time Frame: up to 8 days
|
up to 8 days
|
Measurement of the plasma protein binding of total [14C] radioactivity in human plasma samples ex vivo
Time Frame: up to 8 days
|
up to 8 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with abnormal findings in physical examination
Time Frame: Baseline and within 6 days after discharge
|
Baseline and within 6 days after discharge
|
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Time Frame: Baseline, days 1, 2, 7 and within 6 days after discharge
|
Baseline, days 1, 2, 7 and within 6 days after discharge
|
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)
Time Frame: Baseline, days 1, 2, 7 and within 6 days after discharge
|
Baseline, days 1, 2, 7 and within 6 days after discharge
|
Number of patients with abnormal changes in laboratory parameters
Time Frame: Baseline, days 1, 2 and within 6 days after discharge
|
Baseline, days 1, 2 and within 6 days after discharge
|
Number of patients with adverse events
Time Frame: Up to 22 days
|
Up to 22 days
|
Assessment of tolerability by investigator on a 4-point scale
Time Frame: Day 8
|
Day 8
|
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, 2008
Primary Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
June 20, 2014
First Submitted That Met QC Criteria
June 20, 2014
First Posted (Estimate)
June 24, 2014
Study Record Updates
Last Update Posted (Estimate)
June 24, 2014
Last Update Submitted That Met QC Criteria
June 20, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1245.8
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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