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HealthyPhase 1NCT02256813

Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextromethorphan in Healthy Male Volunteers

A Phase 1 study testing BIRT 2584 XX, Warfarin sodium and Omeprazole 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 study aimed to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 on the Pharmacokinetics (PK) of five probe substrates for cytochrome P450 isozymes. The substrates used to monitor enzyme activity were oral warfarin (for CYP2C9), oral omeprazole (for CYP2C19), oral dextromethorphan (for CYP2D6)… 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?
BIRT 2584 XX, Warfarin sodium and Omeprazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Sep 2005to Dec 2005
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

  • age ≥ 18 and ≤55 years
  • BMI ≥ 18.5 and ≤ 29.9 kg/m2
  • healthy male subjects as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG at the screening visit
  • signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
  • non-smoker (a subject is considered to be a non-smoker if he has never smoked or has stopped smoking ≥ 6 months before the screening visit)
  • agree not to take any prescription medications or non-prescription drugs (including herbal preparations and vitamins) without approval by the investigator and not to receive vaccinations during the course of the study
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  • agree not to eat oranges, grapefruits, broccoli, Brussels sprouts, or char grilled meats and not to drink grapefruit juice during the course of the study
  • agree not to drink alcoholic beverages during the course of the study
  • agree not to drink or eat caffeine and theobromine containing beverages and foods during the course of the study

Who cannot join

  • any finding of the medical examination (including Blood Pressure, Pulse Rate, and ECG) deviating from normal and of clinical relevance
  • gastrointestinal, hepatic, renal, respiratory (e.g. asthma), cardiovascular, metabolic, immunologic, haematological, oncological, or hormonal disorders
  • any surgical or medical condition that could interfere with the administration of the study drug or interpretation of the study results
  • diseases of the Central nervous system (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders
  • relevant history of orthostatic hypotension, fainting spells, or blackouts
  • chronic or relevant acute infections
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  • history of allergy/hypersensitivity (including drug allergy) considered relevant to the trial as judged by the investigator
  • immunisation during the 2 weeks prior to the screening visit
  • known intolerance to benzodiazepines
  • known intolerance to the active and/or inactive ingredients in caffeine, warfarin, vitamin K1, omeprazole, or dextromethorphan
  • known acute angle-closure glaucoma
  • elevated prothrombin time as determined by Prothrombin time (INR) > 1.3
  • intake of drugs with a long half-life (greater than 24 hrs) (less than one month prior to administration or during the trial)
  • use of any drugs which might influence the results of the trial (less than 10 days prior to study drug administration or expected during the trial)
  • use of chewing tobacco or nicotine replacement devices within 6 months before the screening visit
  • participation in another trial with an investigational drug within 2 months prior to administration or during the trial
  • alcohol abuse (more than 60 g of ethanol per day)
  • blood donation or loss greater than 100 mL (less than one month prior to administration or expected during the trial)
  • clinically relevant laboratory abnormalities

About this study

Official title: A Study to Evaluate the Effect of Multiple Doses of 500 mg of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextromethorphan Dosed Orally and Midazolam Dosed IV, in Healthy Male Volunteers

The study aimed to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 on the Pharmacokinetics (PK) of five probe substrates for cytochrome P450 isozymes.

The substrates used to monitor enzyme activity were oral warfarin (for CYP2C9), oral omeprazole (for CYP2C19), oral dextromethorphan (for CYP2D6), oral caffeine (for CYP1A2) and intravenous midazolam (for hepatic CYP3A)

Conditions
Healthy
Being tested
BIRT 2584 XX, Warfarin sodium, Omeprazole, Dextromethorphan hydrobromide, Caffeine

What participants receive

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

  • BIRT 2584 XXDrug

  • Warfarin sodiumDrug

    Also called Coumadin®

  • OmeprazoleDrug

    Also called Omeprazole-ratiopharm® NT

  • Dextromethorphan hydrobromideDrug

    Also called Hustenstiller-ratiopharm®

  • CaffeineDrug

    Also called Coffeinum®

  • Midazolam hydrochlorideDrug

    Also called Dormicum®

  • Vitamin K1Drug

    Also called Konakion®

Study groups in NCT02256813
Study groupRoleWhat they receive
BIRT 2584 XX + PK-cocktailExperimentalNot described
Receives: Drug: BIRT 2584 XX; Drug: Warfarin sodium; Drug: Omeprazole; Drug: Dextromethorphan hydrobromide; Drug: Caffeine; Drug: Midazolam hydrochloride; Drug: Vitamin K1

What is being measured

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

  1. AUC0-inf (Area under the concentration-time curve of midazolam IV and S-warfarin in plasma over the time interval from 0 extrapolated to infinity)

    Measured: up to day 19

  2. AUC (Area under the concentration-time curve of the ratio of omeprazole to 5-hydroxyomeprazole in plasma)

    Measured: up to day 19

  3. 0-12 hr urinary molar ratio of caffeine metabolites (1-Methylxanthine + 1-Methylurate +5-Acetylamino-6-formylamino-3-methyluracil)/ 1,7-Dimethylurate

    Measured: up to 12 hours after administration

  4. 0-12 hr urinary dextromethorphan/dextrorphan ratio

    Measured: up to 12 hours after administration

Secondary outcomes (13)

  1. AUC0-tz (Area under the concentration-time curve of the S-warfarin, omeprazole and midazolam IV in plasma over the time interval from 0 to the time of the last quantifiable data point)

    Measured: up to day 19

  2. Cmax (Maximum measured concentration of the S-warfarin, omeprazole and midazolam IV in plasma)

    Measured: up to day 19

  3. tmax (Time from dosing to the maximum concentration of the S-warfarin, omeprazole and midazolam IV in plasma)

    Measured: up to day 19

  4. λz (Terminal rate constant of the S-warfarin, omeprazole and midazolam IV in plasma)

    Measured: up to day 19

  5. t1/2 (Terminal rate constant of the S-warfarin, omeprazole and midazolam IV in plasma)

    Measured: up to day 19

  6. MRT (Mean residence time of the S-warfarin, omeprazole and midazolam IV in the body after administration)

    Measured: up to day 19

  7. CL/F (Apparent clearance of the S-warfarin, omeprazole and midazolam IV in plasma after extravascular single dose administration)

    Measured: up to day 19

  8. Vz/F (Apparent volume of distribution during the terminal phase λz following extravascular administration S-warfarin, omeprazole and midazolam IV)

    Measured: up to day 19

  9. AUC0-inf (Area under the concentration-time curve of omeprazole in plasma over the time interval from 0 extrapolated to infinity)

    Measured: up to day 19

  10. trough levels of BIRT 2584 XX and BI 610100

    Measured: up to day 19

  11. approximate peak levels of BIRT 2584 XX and BI 610100

    Measured: up to day 19

  12. Number of subjects with adverse events

    Measured: up to 48 days

  13. Number of subjects with abnormal changes in laboratory parameters

    Measured: up to 48 days

Timeline

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

  1. First posted6 Oct 2014 (estimated)
  2. Study startSep 2005
  3. Primary completionDec 2005

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02256813
Sponsor's protocol ID
1206.10
Status last verified
Oct 2014
First submitted
2 Oct 2014
Last updated
6 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIRT 2584 XX, Warfarin sodium and Omeprazole 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 9 inclusion and 19 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 6 Oct 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-inf (Area under the concentration-time curve of midazolam IV and S-warfarin in plasma over the time interval from 0 extrapolated to infinity) (time frame: up to day 19). 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 NCT02256813.

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 6 Oct 2014.

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