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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

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ClinicalTrials.gov Identifier: NCT02221375
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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 (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).

Condition or disease Intervention/treatment Phase
Healthy Drug: BHT low Drug: BHT medium Drug: BHT high Drug: BI 54903 XX low Drug: BI 54903 XX medium 1 Drug: BI 54903 XX medium 2 Drug: BI 54903 XX high Drug: Ciclesonide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)
Study Start Date : June 2008
Actual Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BHT low Drug: BHT low
Experimental: BHT medium Drug: BHT medium
Experimental: BHT high Drug: BHT high
Experimental: BI 54903 XX low Drug: BI 54903 XX low
Experimental: BI 54903 XX medium 1 Drug: BI 54903 XX medium 1
Experimental: BI 54903 XX medium 2 Drug: BI 54903 XX medium 2
Experimental: BI 54903 XX high Drug: BI 54903 XX high
Experimental: BI 54903 XX medium single dose Drug: BI 54903 XX medium 2
Active Comparator: Ciclesonide Drug: Ciclesonide



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 21 days after last drug administration ]
  2. Number of patients with clinically significant findings in vitals signs [ Time Frame: up to 21 days after last drug administration ]
  3. Number of patients with clinically significant findings in ECG [ Time Frame: up to 21 days after last drug administration ]
  4. Number of patients with clinically significant findings in laboratory tests [ Time Frame: up to 21 days after last drug administration ]
  5. Investigator assessed tolerability on a 4-point scale [ Time Frame: up to 21 days after last drug administration ]
  6. Change in airway resistance (Raw) [ Time Frame: baseline, after 80 hours ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration in plasma) [ Time Frame: up to 24 hours after last drug administration ]
  2. tmax (time from dosing to maximum measured concentration in plasma) [ Time Frame: up to 24 hours after last drug administration ]
  3. AUCτ (area under the concentration-time curve in plasma over a uniform dosing interval τ) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: up to 24 hours after last drug administration ]
  7. %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) [ Time Frame: up to 24 hours after last drug administration ]
  8. λz (terminal rate constant in plasma) [ Time Frame: up to 24 hours after last drug administration ]
  9. t1/2 (terminal half-life in plasma) [ Time Frame: up to 24 hours after last drug administration ]
  10. MRTih (mean residence time in the body after inhalation administration) [ Time Frame: up to 24 hours after last drug administration ]
  11. CL/F (apparent clearance in plasma following inhalation administration) [ Time Frame: up to 24 hours after last drug administration ]
  12. Vz/F (apparent volume of distribution during the terminal phase λz following inhalation administration) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: up to 24 hours after last drug administration ]
  15. CLR,t1-t2 (renal clearance from the time point t1 until the time point t2) [ Time Frame: up to 24 hours after last drug administration ]
  16. Accumulation ratio based on Cmax (RA,Cmax) [ Time Frame: up to 24 hours after last drug administration ]
  17. Accumulation ratio based on AUC (RA,AUC) [ Time Frame: up to 24 hours after last drug administration ]
  18. Linearity index (LI) [ Time Frame: up to 24 hours after last drug administration ]
  19. Metabolite-to-parent ratio for Cmax (RCmax,Met) [ Time Frame: up to 24 hours after last drug administration ]
  20. Metabolite-to-parent ratio for AUC (AUCt1-t2,Met) [ Time Frame: up to 24 hours after last drug administration ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02221375     History of Changes
Other Study ID Numbers: 1256.1
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Ciclesonide
Butylated Hydroxytoluene
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents