Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Spray Dried BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers

NCT02199860 | Completed Phase 1

• 1 other identifier: 1149.44
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of spray-dried powder in healthy male and female volunteers. According to the original protocol, the primary objective was to investigate the safety and tolerability of single doses of a new spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD II with and without concomitant administration of lactose

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with adverse events

  up to 25 days

• Assessment of tolerability on a 4-point scale

  8 days after drug administration

• Change in lung function measurements airway resistance (Raw)

  up to 5 hours after drug administration

• Change in lung function measurement specific conductance (SGaw)

  up to 5 hours after drug administration

• Change in lunf function measurement forced expiratory volume in 1 second (FEV1)

  up to 5 hours after drug administration

Secondary Outcomes (9)

• Cmax (Maximum measured concentration of the analyte in plasma)

  up to 48 hours after drug administration

• tmax (Time from dosing to the maximum concentration of the analyte in plasma)

  up to 48 hours after drug administration

• AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 48 hours after drug administration

• AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

  up to 48 hours after drug administration

• λz (Terminal rate constant in plasma)

  up to 48 hours after drug administration

Study Arms (4)

SD I - single rising doses

EXPERIMENTAL

Drug: SD I

SD II - single rising doses

EXPERIMENTAL

Drug: SD II

SD II - single rising doses + Placebo

EXPERIMENTAL

Drug: SD II; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SD I DRUG

SD I - single rising doses

SD II DRUG

SD II - single rising doses; SD II - single rising doses + Placebo

Placebo DRUG

Placebo; SD II - single rising doses + Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects could be included in the study if they met the following criteria:
• Healthy male or female volunteers
• Written informed consent in accordance with Good Clinical Practice (GCP) and the local legislation prior to admission to the study
• Age 21 - 50 years
• Body mass index (BMI): 18.5 - 29.9 kg/m2

You may not qualify if:

• Subjects were not allowed to participate if any of the following applied:
• Any finding of the medical examination (including blood pressure, pulse rate, Respiratory rate, body temperature and ECG) deviating from normal and of clinical relevance
• Raw \> 3 cm H2O • s • L-1 or FEV1 \<80% of predicted
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system, psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts,
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug before enrolment in the study
• Use of any drugs which might influence the results of the trial (within 1 week prior to administration of investigational drug or during the trial)
• Participation in another trial with an investigational drug (within 2 months prior to drug administration or during the trial)
• Smoker (\>10 cigarettes/day or \>3 cigars/day or \>3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (\>60 gram/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

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

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 25, 2014
• Study Start: May 1, 2003
• Primary Completion: February 1, 2004
• Last Updated: July 25, 2014

Record last verified: 2014-07