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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [14C]-BI 10773 - oral solution
Drug: [14C]-BI 10773 - oral solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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