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

NCT ID: NCT02221375

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BHT low

Group Type: EXPERIMENTAL

BHT low

Intervention Type: DRUG

BHT medium

Group Type: EXPERIMENTAL

BHT medium

Intervention Type: DRUG

BHT high

Group Type: EXPERIMENTAL

BHT high

Intervention Type: DRUG

BI 54903 XX low

Group Type: EXPERIMENTAL

BI 54903 XX low

Intervention Type: DRUG

BI 54903 XX medium 1

Group Type: EXPERIMENTAL

BI 54903 XX medium 1

Intervention Type: DRUG

BI 54903 XX medium 2

Group Type: EXPERIMENTAL

BI 54903 XX medium 2

Intervention Type: DRUG

BI 54903 XX high

Group Type: EXPERIMENTAL

BI 54903 XX high

Intervention Type: DRUG

BI 54903 XX medium single dose

Group Type: EXPERIMENTAL

BI 54903 XX medium 2

Intervention Type: DRUG

Ciclesonide

Group Type: ACTIVE_COMPARATOR

Ciclesonide

Intervention Type: DRUG

Interventions

BHT low

Intervention Type: DRUG

BHT medium

Intervention Type: DRUG

BHT high

Intervention Type: DRUG

BI 54903 XX low

Intervention Type: DRUG

BI 54903 XX medium 1

Intervention Type: DRUG

BI 54903 XX medium 2

Intervention Type: DRUG

BI 54903 XX high

Intervention Type: DRUG

Ciclesonide

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1256.1

Identifier Type: -

Identifier Source: org_study_id