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HealthyPhase 1NCT02183428

Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers

A Phase 1 study testing BI 1356, Glyburide and BI 1356 + Glyburide 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

The objective of this study was to investigate the effect of multiple doses BI 1356 given once daily in the estimated highest therapeutic dose of 5 mg until steady state on the pharmacokinetics, safety, and tolerability of a single oral conventional therapeutic dose of 1.75 mg glyburide. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BI 1356, Glyburide and BI 1356 + Glyburide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
May 2008to Jul 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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Any finding of the medical examination (including BP, PR 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 31Show 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, including herbal products
  • 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 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, hypokalaemia, family history of Long QT Syndrome)
  • Galactose intolerance
  • Lactase deficiency
  • Glucose-galactose-malabsorption
  • For all female subjects:
  • Pregnancy or planning to become pregnant within 2 months of study completion
  • Positive pregnancy test
  • No adequate contraception e.g. , sterilisation, IUD (intrauterine device), have not been using a barrier method of contraception for at least 3 months prior to participation in the study
  • Not willing or unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial
  • Partner is unwilling to use condoms
  • Lactation period

About this study

Official title: Relative Bioavailability of BI 1356 and Glyburide After Concomitant Administration of Multiple Oral Doses of BI 1356 5 mg Once Daily and a Single Oral Dose of Glyburide 1.75 mg Compared With the Bioavailability of BI 1356 and Glyburide After Each Treatment Given Alone in Healthy Male and Female Volunteers (an Open Label, Randomised, Two-way Crossover Study of Phase I)

The objective of this study was to investigate the effect of multiple doses BI 1356 given once daily in the estimated highest therapeutic dose of 5 mg until steady state on the pharmacokinetics, safety, and tolerability of a single oral conventional therapeutic dose of 1.75 mg glyburide. In addition, the effect of glyburide as a single oral dose of 1.75 mg being a conventional therapeutic dose on the multiple dose pharmacokinetics of BI 1356 was investigated. Pharmacokinetic profiles of glyburide were determined when given alone or in combination with BI 1356. Pharmacokinetic profiles of BI 1356 and its inactive metabolite CD 1750 were determined at steady state of BI 1356 when given alone or in combination with glyburide.

Conditions
Healthy
Being tested
BI 1356, Glyburide, BI 1356 + Glyburide

What participants receive

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

  • BI 1356Drug

  • GlyburideDrug

  • BI 1356 + GlyburideDrug

Study groups in NCT02183428
Study groupRoleWhat they receive
BI 1356ExperimentalTreatment sequence AB_C or C_AB * Treatment A: 5 days of treatment with BI 1356 once per day until steady state followed by * Treatment B: 1 day of combined treatment of BI1356 and glyburide * Treatment C: 1 day of treatment with glyburide alone
Receives: Drug: BI 1356; Drug: Glyburide; Drug: BI 1356 + Glyburide
GlyburideActive comparatorTreatment sequence AB_C or C_AB * Treatment A: 5 days of treatment with BI 1356 once per day until steady state followed by * Treatment B: 1 day of combined treatment of BI1356 and glyburide * Treatment C: 1 day of treatment with glyburide alone
Receives: Drug: BI 1356; Drug: Glyburide; Drug: BI 1356 + Glyburide

What is being measured

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

  1. AUC0-infinity (area under the concentration-time curve of glyburide in plasma) for several time points

    Measured: up to 48 hours after drug administration

  2. Cmax (maximum measured concentration of glyburide in plasma) for several time points

    Measured: up to 48 hours after drug administration

  3. AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 1356

    Measured: up to 48 h after drug administration

  4. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 1356

    Measured: up to 48 h after drug administration

Secondary outcomes (10)

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

    Measured: up to 48 hours after drug administration

  2. λz (terminal rate constant in plasma)

    Measured: up to 48 hours after drug administration

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

    Measured: up to 48 hours after drug administration

  4. MRTpo (mean residence time of the analyte in the body after po administration) for several time points

    Measured: up to 48 hours after drug administration

  5. CL/F (apparent clearance of the analyte in the plasma after extravascular administration) for several time points

    Measured: up to 48 hours after drug administration

  6. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) for several time points

    Measured: up to 48 hours after drug administration

  7. Number of patients with adverse events

    Measured: up to 11 weeks

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

    Measured: Day 1 of treatment B, day 3 of treatment B and C

  9. AUC (area under the concentration-time curve of the analyte in plasma) for several time points

    Measured: up to 48 h after drug administration

  10. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1750

    Measured: up to 48 h after drug administration

Timeline

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

  1. First posted8 Jul 2014 (estimated)
  2. Study startMay 2008
  3. Primary completionJul 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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02183428
Sponsor's protocol ID
1218.30
Status last verified
Jul 2014
First submitted
4 Jul 2014
Last updated
8 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 1356, Glyburide and BI 1356 + Glyburide 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 31 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 8 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. 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-infinity (area under the concentration-time curve of glyburide in plasma) for several time points (time frame: up to 48 hours after drug administration). The study lists 4 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 NCT02183428.

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 8 Jul 2014.

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