HealthyPhase 1NCT02182453
Single Rising Oral Doses of BI 10773 in Healthy Male Volunteers
A Phase 1 study testing BI 10773 - single rising dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 10773 administered to healthy Japanese male subjects with single rising oral doses (1, 5, 10, 25, and 100 mg). Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 10773 - single rising dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers who meet the following criteria:
- Without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
- Age ≥20 and Age ≤35 years
- Body Mass Index (BMI) ≥18.0 and ≤25.0 kg/m2
- Persons who are willing to participate in this trial and who give their written consent before study initiation in accordance with the Good Clinical Practice (GCP)
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate, body temperature, 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
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
Show all 27Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to a 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 before administration of the investigational product or during the trial
- Use of any drugs within 10 days before administration of the investigational product or during the trial
- Participation in another trial with an investigational drug within four months before administration of the investigational product or during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse
- Drug abuse
- Blood donation (100 mL or more) within four weeks before administration of the investigational product or during the trial
- Excessive physical activities within one week before administration of the investigational product or during the trial
- Basically, a patient with a laboratory value outside the reference range of the clinical site will be excluded form the study. However, if the principal investigator does not see any problem for the subject to enter the study based on the result of assessment of physical examination and other clinical examination, the subject will be able to participate in the study. In this regard, however, subjects who meet one of the following criteria will be excluded from the study:
- FPG (Fasting plasma glucose) ≥110mg/dL
- eGFR (estimated glomerular filtration rate) <60
- abnormal value of urinalysis
- Inability to comply with dietary regimen of the study centre
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for TdP (torsade de pointes) (e.g., heart failure, hypokalemia, family history of long QT syndrome)Samsung2014
- Renal glucosuria or elevated urinary glucose levels at screening (>15 mg/dl)
- Any abnormal finding in Kidney or patients who have history of renal disease
- Any other clinical conditions that investigator or sub-investigator judges that the subject is ineligible for study participation
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 to 100 mg) of BI 10773 in Healthy Male Volunteers
Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 10773 administered to healthy Japanese male subjects with single rising oral doses (1, 5, 10, 25, and 100 mg).
- Conditions
- Healthy
- Being tested
- BI 10773 - single rising dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 10773 - single rising doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 10773 - single rising dose | Experimental | Not described Receives: Drug: BI 10773 - single rising dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: Up to 7 days
Number of patients with abnormal changes in laboratory parameters
Measured: Baseline, day 2-4 and day 7
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate, and body temperature)
Measured: Baseline, day 1-4 and day 7
Number of patients with clinical significant changes in 12-lead ECG (electrocardiogram)
Measured: Baseline, day 1-4 and day 7
Assessment of tolerability on a 4-point scale
Measured: Day 4
Secondary outcomes (13)
Cmax (maximum concentration of the analyte in plasma)
Measured: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
tmax (time from dosing to maximum concentration)
Measured: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Measured: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
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)
Measured: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
λz (terminal rate constant in plasma)
Measured: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
t1/2 (terminal half-life of the analyte in plasma)
Measured: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
MRTpo (mean residence time of the analyte in the body after po administration)
Measured: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
CL/F (total clearance of the analyte in the plasma after extravascular administration)
Measured: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Measured: 2 hours before and 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-34, 34-48, and 48-72 hours after administration of study drug
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: 2 hours before and 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-34, 34-48, and 48-72 hours after administration of study drug
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: 2 hours before and 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-34, 34-48, and 48-72 hours after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJun 2008
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182453
- Sponsor's protocol ID
- 1245.5
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 to 100 mg) of BI 10773 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02182453
- Acronym / sponsor ID
- 1245.5
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 10773 administered to healthy Japanese male subjects with single rising oral doses (1, 5, 10, 25, and 100 mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 10773 - single rising dose | Experimental | Drug: BI 10773 - single rising dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers who meet the following criteria:
Key exclusion criteria (27 listed)
- Any finding of the medical examination (including blood pressure, pulse rate, body temperature, 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
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 |
|---|---|---|
| BI 10773 - single rising dose | Drug | BI 10773 - single rising dose |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with adverse events
Time frame: Up to 7 days
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline, day 2-4 and day 7
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate, and body temperature)
Time frame: Baseline, day 1-4 and day 7
Number of patients with clinical significant changes in 12-lead ECG (electrocardiogram)
Time frame: Baseline, day 1-4 and day 7
Assessment of tolerability on a 4-point scale
Time frame: Day 4
13 secondary outcomes
Cmax (maximum concentration of the analyte in plasma)
Time frame: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
tmax (time from dosing to maximum concentration)
Time frame: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
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: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
λz (terminal rate constant in plasma)
Time frame: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
CL/F (total clearance of the analyte in the plasma after extravascular administration)
Time frame: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Time frame: 2 hours before and 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-34, 34-48, and 48-72 hours after administration of study drug
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: 2 hours before and 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-34, 34-48, and 48-72 hours after administration of study drug
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: 2 hours before and 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-34, 34-48, and 48-72 hours after administration of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 10773 - single rising dose in people with Healthy, run by Boehringer Ingelheim.
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 5 inclusion and 27 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 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with adverse events (time frame: Up to 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2014.