Safety, Tolerability and Pharmacokinetics of Multiple Ris... | NCT02221375

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)

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
BHT low	Experimental	Drug: BHT low
BHT medium	Experimental	Drug: BHT medium
BHT high	Experimental	Drug: BHT high
BI 54903 XX low	Experimental	Drug: BI 54903 XX low
BI 54903 XX medium 1	Experimental	Drug: BI 54903 XX medium 1
BI 54903 XX medium 2	Experimental	Drug: BI 54903 XX medium 2
BI 54903 XX high	Experimental	Drug: BI 54903 XX high
BI 54903 XX medium single dose	Experimental

Name	Type	Description	Arm Group Labels	Other Names
BHT low	Drug		BHT low
BHT medium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with adverse events		up to 21 days after last drug administration
Number of patients with clinically significant findings in vitals signs		up to 21 days after last drug administration
Number of patients with clinically significant findings in ECG		up to 21 days after last drug administration
Number of patients with clinically significant findings in laboratory tests		up to 21 days after last drug administration
Investigator assessed tolerability on a 4-point scale		up to 21 days after last drug administration
Change in airway resistance (Raw)		baseline, after 80 hours

Secondary Outcomes

Measure	Description	Time Frame
Cmax (maximum measured concentration in plasma)		up to 24 hours after last drug administration
tmax (time from dosing to maximum measured concentration in plasma)		up to 24 hours after last drug administration

Eligibility Module

Eligibility 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