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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 54903 XX low; Drug: BI 54903 XX medium 2; Drug: BHT low; Drug: BI 54903 XX high; Drug: BHT medium; Drug: BI 54903 XX medium 1; Drug: BHT high; Drug: Ciclesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02221375

1256.1

Details and patient eligibility

About

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).

Enrollment: 56 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 9 patient groups

BHT low

Experimental group

Treatment:

Drug: BHT low

BHT medium

Experimental group

Treatment:

Drug: BHT medium

BHT high

Experimental group

Treatment:

Drug: BHT high

BI 54903 XX low

Experimental group

Treatment:

Drug: BI 54903 XX low

BI 54903 XX medium 1

Experimental group

Treatment:

Drug: BI 54903 XX medium 1

BI 54903 XX medium 2

Experimental group

Treatment:

Drug: BI 54903 XX medium 2

BI 54903 XX high

Experimental group

Treatment:

Drug: BI 54903 XX high

BI 54903 XX medium single dose

Experimental group

Treatment:

Drug: BI 54903 XX medium 2

Ciclesonide

Active Comparator group

Treatment:

Drug: Ciclesonide