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

NCT02221375 | Completed Phase 1

• 1 other identifier: 1256.1
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (6)

• 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 (20)

• 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

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

  up to 24 hours after last drug administration

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

  up to 24 hours after last drug administration

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

  up to 24 hours after last drug administration

Study Arms (9)

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

Drug: BI 54903 XX medium 2

Ciclesonide

ACTIVE COMPARATOR

Drug: Ciclesonide

Interventions

BHT low DRUG

BHT low

BHT medium DRUG

BHT medium

BHT high DRUG

BHT high

BI 54903 XX low DRUG

BI 54903 XX low

BI 54903 XX medium 1 DRUG

BI 54903 XX medium 1

BI 54903 XX medium 2 DRUG

BI 54903 XX medium 2; BI 54903 XX medium single dose

BI 54903 XX high DRUG

BI 54903 XX high

Ciclesonide DRUG

Ciclesonide

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

ciclesonide

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: June 1, 2008
• Primary Completion: September 1, 2008
• Last Updated: August 20, 2014

Record last verified: 2014-08