AzTrials
AzTrials

HealthyPhase 1NCT02221375

Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Butylated Hydroxytoluene and BI 54903 XX Via Respimat® Soft MistTM Inhaler B in Healthy Male Volunteers

A Phase 1 study testing BHT low, BHT medium and BHT high 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
Search all trials

Trial summary

The objective of the study was to investigate safety, tolerability and pharmacokinetics of butylated hydroxytoluene (BHT) (sub-study 1) administered via Respimat® Soft MistTM Inhaler B (SMI B); to assess safety, tolerability and pharmacokinetics of multiple rising doses of BI 54903 XX administered via Respimat® SMI B… Read more about this study

Who is it for?
Ages 21 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BHT low, BHT medium and BHT high
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
Jun 2008to Sep 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 21 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG) and 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 20Show 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 h) 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 that could reasonably influence the results of the trial within 10 days prior to administration or during the trial (based on the knowledge at the time of protocol preparation)
  • Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
  • Smoker (>10 cigarettes or >3 cigars or >3 pipes per day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 60 g per day)
  • Drug abuse
  • Blood donation (>100 mL within 4 weeks prior to administration or during the trial)
  • Excessive physical activities (within 1 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 the trial site
  • Bacterial and viral infections of the lung, including active or latent tuberculosis

About this study

Official title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses of Butylated Hydroxytoluene Via Respimat Soft MistTM Inhaler B (Sub-study 1) and Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses of BI 54903 XX Via Respimat Soft MistTM Inhaler B as Randomised, Double-blind, Placebo-controlled Phase I Trial in Healthy Male Volunteers (Main Study) and Comparison of Systemic Exposure Following a Single Dose of BI 54903 XX Via Respimat Soft MistTM Inhaler B and of a Single Dose of Ciclesonide Via MDI (Randomised, Open-label, Two-way Crossover Sub-study 2)

The objective of the study was to investigate safety, tolerability and pharmacokinetics of butylated hydroxytoluene (BHT) (sub-study 1) administered via Respimat® Soft MistTM Inhaler B (SMI B); to assess safety, tolerability and pharmacokinetics of multiple rising doses of BI 54903 XX administered via Respimat® SMI B (main study), and to compare systemic exposure of single dose BI 54903 XX administered via Respimat® SMI B (sub-study 2) with single dose Alvesco® (ciclesonide) administered via HFA-134a propellant metered dose inhaler (MDI).

Conditions
Healthy
Being tested
BHT low, BHT medium, BHT high, BI 54903 XX low, BI 54903 XX medium 1

What participants receive

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

  • BHT lowDrug

  • BHT mediumDrug

  • BHT highDrug

  • BI 54903 XX lowDrug

  • BI 54903 XX medium 1Drug

  • BI 54903 XX medium 2Drug

  • BI 54903 XX highDrug

  • CiclesonideDrug

Study groups in NCT02221375
Study groupRoleWhat they receive
BHT lowExperimentalNot described
Receives: Drug: BHT low
BHT mediumExperimentalNot described
Receives: Drug: BHT medium
BHT highExperimentalNot described
Receives: Drug: BHT high
BI 54903 XX lowExperimentalNot described
Receives: Drug: BI 54903 XX low
BI 54903 XX medium 1ExperimentalNot described
Receives: Drug: BI 54903 XX medium 1
BI 54903 XX medium 2ExperimentalNot described
Receives: Drug: BI 54903 XX medium 2
BI 54903 XX highExperimentalNot described
Receives: Drug: BI 54903 XX high
BI 54903 XX medium single doseExperimentalNot described
Receives: Drug: BI 54903 XX medium 2
CiclesonideActive comparatorNot described
Receives: Drug: Ciclesonide

What is being measured

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

  1. Number of patients with adverse events

    Measured: up to 21 days after last drug administration

  2. Number of patients with clinically significant findings in vitals signs

    Measured: up to 21 days after last drug administration

  3. Number of patients with clinically significant findings in ECG

    Measured: up to 21 days after last drug administration

  4. Number of patients with clinically significant findings in laboratory tests

    Measured: up to 21 days after last drug administration

  5. Investigator assessed tolerability on a 4-point scale

    Measured: up to 21 days after last drug administration

  6. Change in airway resistance (Raw)

    Measured: baseline, after 80 hours

Secondary outcomes (20)

  1. Cmax (maximum measured concentration in plasma)

    Measured: up to 24 hours after last drug administration

  2. tmax (time from dosing to maximum measured concentration in plasma)

    Measured: up to 24 hours after last drug administration

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

    Measured: up to 24 hours after last drug administration

  4. AUC0-inf (area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity)

    Measured: up to 24 hours after last drug administration

  5. AUCt1-t2 (area under the concentration-time curve in plasma over the time interval from time t1 to time t2)

    Measured: up to 24 hours after last drug administration

  6. AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the last quantifiable concentration at tz)

    Measured: up to 24 hours after last drug administration

  7. %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)

    Measured: up to 24 hours after last drug administration

  8. λz (terminal rate constant in plasma)

    Measured: up to 24 hours after last drug administration

  9. t1/2 (terminal half-life in plasma)

    Measured: up to 24 hours after last drug administration

  10. MRTih (mean residence time in the body after inhalation administration)

    Measured: up to 24 hours after last drug administration

  11. CL/F (apparent clearance in plasma following inhalation administration)

    Measured: up to 24 hours after last drug administration

  12. Vz/F (apparent volume of distribution during the terminal phase λz following inhalation administration)

    Measured: up to 24 hours after last drug administration

  13. Aet1-t2 (amount that is eliminated in urine from the time point t1 to time point t2)

    Measured: up to 24 hours after last drug administration

  14. fet1-t2 (fraction that is eliminated in urine from time point t1 to time point t2)

    Measured: up to 24 hours after last drug administration

  15. CLR,t1-t2 (renal clearance from the time point t1 until the time point t2)

    Measured: up to 24 hours after last drug administration

  16. Accumulation ratio based on Cmax (RA,Cmax)

    Measured: up to 24 hours after last drug administration

  17. Accumulation ratio based on AUC (RA,AUC)

    Measured: up to 24 hours after last drug administration

  18. Linearity index (LI)

    Measured: up to 24 hours after last drug administration

  19. Metabolite-to-parent ratio for Cmax (RCmax,Met)

    Measured: up to 24 hours after last drug administration

  20. Metabolite-to-parent ratio for AUC (AUCt1-t2,Met)

    Measured: up to 24 hours after last 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 startJun 2008
  3. Primary completionSep 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
Parallel groups
Masking
Double blind
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02221375
Sponsor's protocol ID
1256.1
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 BHT low, BHT medium and BHT high 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 20 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?

Number of patients with adverse events (time frame: up to 21 days after last drug administration). The study lists 6 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 NCT02221375.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in