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HealthyPhase 1NCT02220660

Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of BI 1744 CL Plus BI 54903 XX Via Respimat® B Versus the Free Combination of BI 1744 CL Via Respimat® A and BI 54903 XX Via Respimat® B in Healthy Male and Female Volunteers

A Phase 1 study testing BI 1744 CL, BI 54903 XX and BI 1744 CL + BI 54903 XX FDC 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 primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD 1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following inhalation of the fixed dose combination (FDC) BI 1744 CL plus BI 54903 XX (as ethanolic solution for inhalation, EIS) with the systemic… Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BI 1744 CL, BI 54903 XX and BI 1744 CL + BI 54903 XX FDC
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
No sites listed yet
Study dates
Mar 2009to Jun 2009
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 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males and females 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 >= 21 and <= 50 years
  • BMI >= 18.5 and <= 29.9 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) 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/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 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 40 g/day)
  • Drug abuse
  • Blood donation (> 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
  • For female Subjects:
  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception (adequate contraception e.g. sterilization, intrauterine pessary (IUP), oral contraceptives)
  • Inability to maintain this adequate contraception during the whole study period
  • Lactation period
  • Exclusion criteria specific for this study due to the known class side effect profile of ß2-mimetics and inhaled corticosteroids:
  • Asthma or history of pulmonary hyperreactivity
  • Hyperthyreosis
  • Allergic rhinitis in need of treatment
  • Clinically relevant cardiac arrhythmia
  • Bacterial and viral infections of the lung including tuberculosis

About this study

Official title: A Single-blind, Randomised, Two-way Crossover Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of BI 1744 CL Plus BI 54903 XX Via Respimat® B Versus the Free Combination of BI 1744 CL Via Respimat® A and BI 54903 XX Via Respimat® B in Healthy Male and Female Volunteers

The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD 1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following inhalation of the fixed dose combination (FDC) BI 1744 CL plus BI 54903 XX (as ethanolic solution for inhalation, EIS) with the systemic exposure following inhalation of the free dose combination of BI 1744 CL (as aqueous solution for inhalation, AIS) and BI 54903 XX (EIS), respectively, when administered once-daily via Respimat® Inhaler (Respimat® A for AIS and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary objectives were: to compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the BI 1744 CL/BI 54903 XX FDC and the free dose combination, respectively; to compare exposure to BI 54903 XX after a single dose and at steady state after multiple doses of the BI 1744 CL/BI 54903 XX fixed dose combination and the free dose combination, respectively; to compare the safety and tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI 54903 XX fixed dose combination and as the free dose combination, respectively.

Conditions
Healthy
Being tested
BI 1744 CL, BI 54903 XX, BI 1744 CL + BI 54903 XX FDC, Placebo

What participants receive

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

  • BI 1744 CLDrug

  • BI 54903 XXDrug

  • BI 1744 CL + BI 54903 XX FDCDrug

  • PlaceboDrug

Study groups in NCT02220660
Study groupRoleWhat they receive
Free dose combinationActive comparatorNot described
Receives: Drug: BI 1744 CL; Drug: BI 54903 XX
Fixed dose combinationExperimentalNot described
Receives: Drug: BI 1744 CL + BI 54903 XX FDC; Drug: Placebo

What is being measured

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

  1. AUC0-t,ss (area under the concentration time curve of the analyte in plasma from 0 to time t at steady state)

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

Secondary outcomes (14)

  1. AUC0-t,ss (area under the concentration time curve of the analyte in plasma from 0 to time t at steady state)

    Measured: up to 24 hours after drug administration

  2. Cpre (pre-dose concentration of the analyte in plasma)

    Measured: immediately before drug administration

  3. AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)

    Measured: up to 24 hours after drug administration

  4. AUC0-t (area under the concentration time curve of the analyte in plasma from 0 to time t)

    Measured: up to 24 hours after drug administration

  5. 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: up to 24 hours after drug administration

  6. AUCτ (area under the plasma concentration-time curve over a uniform dosing interval τ)

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

  10. λz (terminal rate constant of the analyte in plasma)

    Measured: up to 24 hours after drug administration

  11. t½ (terminal half-life of the analyte in plasma)

    Measured: up to 24 hours after drug administration

  12. MRTih (mean residence time of the analyte in the body after inhaled administration)

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours after drug administration

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

    Measured: up to 24 hours 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 posted20 Aug 2014 (estimated)
  2. Study startMar 2009
  3. Primary completionJun 2009

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
Single blind
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220660
Sponsor's protocol ID
1256.2
Status last verified
Aug 2014
First submitted
19 Aug 2014
Last updated
20 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 1744 CL, BI 54903 XX and BI 1744 CL + BI 54903 XX FDC 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 20 Aug 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-t,ss (area under the concentration time curve of the analyte in plasma from 0 to time t at steady state) (time frame: up to 24 hours after drug administration). 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 NCT02220660.

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 20 Aug 2014.

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