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HealthyPhase 1NCT02172209

Bioavailability and Pharmacokinetics of BI 10773 Tablet in Healthy Male Volunteers

A Phase 1 study testing BI 10773 in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a single dose BI 10773 tablet in healthy subjects Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BI 10773
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
No sites listed yet
Study dates
Jan 2008to Feb 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 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
  • Age ≥ 18 and Age ≤ 55 years
  • BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Who cannot join

  • Any finding in the medical examination (including BP (blood pressure), PR (pulse rate) and ECG (electrocardiogram)) 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 22Show fewer
  • Chronic or relevant acute infections
  • History of relevant allergy or 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 or that prolong the QT/QTc interval 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 on trial days
  • 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 the dietary regimen of trial site
  • 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 torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
  • Elevated urinary glucose levels at screening (> 15 mg/dl; > 0.83 mmol/L)

About this study

Official title: The Effect of Food on the Bioavailability and Pharmacokinetics of BI 10773 Tablet, Administered as a Single Dose of 50 mg With and Without Food to Healthy Male Volunteers in an Open-label, Randomised Intraindividual Crossover Comparison Design

Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a single dose BI 10773 tablet in healthy subjects

Conditions
Healthy
Being tested
BI 10773

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 10773Drug

Study groups in NCT02172209
Study groupRoleWhat they receive
BI 10773 tablet administered with foodExperimental50 mg BI 10773 after a standardised high fat breakfast
Receives: Drug: BI 10773
BI 10773 tablet administered to fasted subjectsActive comparator50 mg BI 10773 p.o. after an overnight fast of at least 10 hours
Receives: Drug: BI 10773

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose

  2. Cmax (maximum measured concentration of the analyte in plasma)

    Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose

Secondary outcomes (16)

  1. tmax (time from dosing to the maximum concentration of the analyte in plasma)

    Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose

  2. t1/2 (terminal half-life of the analyte in plasma)

    Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours after last dose

  3. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)

    Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose

  4. 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: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose

  5. λz (terminal rate constant in plasma)

    Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose

  6. MRTpo (mean residence time of the analyte in the body after p.o. administration)

    Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose

  7. CL/F (apparent clearance of the analyte in the plasma after extravascular administration)

    Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose

  8. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

    Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose

  9. Glucose excretion in urine

    Measured: pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose

  10. Creatinine excretion in urine

    Measured: pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose

  11. Abnormal findings in physical examination

    Measured: Baseline and within 14 days after last trial procedure

  12. Changes from baseline in vital signs (blood pressure, pulse rate)

    Measured: Baseline and within 14 days after last trial procedure

  13. Changes from baseline in 12-lead ECG (electrocardiogram)

    Measured: Baseline and within 14 days after last trial procedure

  14. Changes from baseline in routine laboratory tests

    Measured: Baseline and within 14 days after last trial procedure

  15. Incidence of adverse events

    Measured: Up to 15 days

  16. Assessment of tolerability by investigator on a 4-point scale

    Measured: Within 14 days after last trial procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2014 (estimated)
  2. Study startJan 2008
  3. Primary completionFeb 2008

Resources

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
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02172209
Sponsor's protocol ID
1245.3
Status last verified
Jun 2014
First submitted
20 Jun 2014
Last updated
24 Jun 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 10773 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 4 inclusion and 22 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 24 Jun 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. 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?

AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02172209.

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 24 Jun 2014.

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