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HealthyPhase 1NCT02183389

Bioavailability of Warfarin After Coadministration With Multiple Doses of BI 1356 Compared to the Bioavailability of Warfarin Alone in Healthy Male Volunteers

A Phase 1 study testing Warfarin and BI 1356 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

To investigate whether and to what extent BI 1356 affects pharmacokinetic and pharmacodynamic parameters of warfarin Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Warfarin and BI 1356
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
May 2008to Oct 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 50 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 (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
  • Age ≥ 18 and Age ≤ 50 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 (GCP) and the local legislation
  • Homozygote wild-type carriers (*1/*1) of cytochrome P 450 (CYP) 2C9

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 25Show fewer
  • 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 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 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 Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • Anemia at screening
  • Galactose intolerance
  • Lactase deficiency
  • Glucose-galactose-malabsorption

About this study

Official title: Relative Bioavailability of a Single Oral Dose of Warfarin (10 mg qd) After Coadministration With Multiple Oral Doses of BI 1356 (5 mg qd) Compared to the Bioavailability of a Single Oral Dose of Warfarin (10 mg qd) Alone in Healthy Male Volunteers (an Open Label, Two Periods, Fixed-sequence, Clinical Phase I Study)

To investigate whether and to what extent BI 1356 affects pharmacokinetic and pharmacodynamic parameters of warfarin

Conditions
Healthy
Being tested
Warfarin, BI 1356

What participants receive

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

Study groups in NCT02183389
Study groupRoleWhat they receive
Treatment B: BI 1356 and WarfarinExperimentalBI 1356 for 12 days combined with a single dose of warfarin on day 6
Receives: Drug: Warfarin; Drug: BI 1356
Treatment A: WarfarinActive comparatorWarfarin as single dose
Receives: Drug: Warfarin

What is being measured

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

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

    Measured: Up to 168 hours after start of study medication

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

    Measured: Up to 168 hours after start of study medication

Secondary outcomes (17)

  1. Area under the concentration time curve (AUC) of the analyte in plasma at different time points

    Measured: Up to 168 hours after start of study medication

  2. Time from dosing to the maximum concentration of the analyte in plasma (tmax)

    Measured: Up to 168 hours after start of study medication

  3. Terminal rate constant in plasma (λz)

    Measured: Up to 168 hours after start of study medication

  4. Terminal half life of the analyte in plasma (t1/2)

    Measured: Up to 168 hours after start of study medication

  5. Mean residence time of the analyte in the body after p.o. administration (MRTpo)

    Measured: Up to 168 hours after start of study medication

  6. Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)

    Measured: Up to 168 hours after start of study medication

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

    Measured: Up to 168 hours after start of study medication

  8. Number of patients with adverse events

    Measured: Up 42 days

  9. Number of patients with relevant changes in physical examination

    Measured: Up to 14 days after last study drug administration

  10. Number of patients with relevant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))

    Measured: Up to 14 days after last study drug administration

  11. Number of patients with relevant changes in 12-lead resting electrocardiogram (ECG)

    Measured: Up to 14 days after last study drug administration

  12. Number of patients with relevant changes in laboratory values

    Measured: Up to 14 days after last study drug administration

  13. Assessment of tolerability a 4-point scale by the investigator

    Measured: Up 42 days

  14. International normalised ratio, area under the concentration time curve of the analyte in plasma over the time interval from time zero to 168 hours (INR AUC0-168)

    Measured: Up to 168 hours after start of treatment

  15. International normalised ratio, maximum concentration of the analyte in plasma (INRmax)

    Measured: Up to 168 hours after start of treatment

  16. Prothrombin time, area under the concentration time curve of the analyte in plasma over the time interval from time zero to 168 hours (PT AUC0-168)

    Measured: Up to 168 hours after start of treatment

  17. Prothrombin time, maximum concentration of the analyte in plasma (PTmax)

    Measured: Up to 168 hours after start of treatment

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 completionOct 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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02183389
Sponsor's protocol ID
1218.28
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 Warfarin and BI 1356 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 6 inclusion and 25 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?

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: Up to 168 hours after start of study medication). 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 NCT02183389.

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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