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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

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ClinicalTrials.gov Identifier: NCT02199860
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: SD I Drug: SD II Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind (at Each Dose Level), Randomised, Placebo-controlled, Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Two Spray-dried Formulations of BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers
Study Start Date : May 2003
Actual Primary Completion Date : February 2004

Arm Intervention/treatment
Experimental: SD I - single rising doses Drug: SD I
Experimental: SD II - single rising doses Drug: SD II
Experimental: SD II - single rising doses + Placebo Drug: SD II
Drug: Placebo
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 25 days ]
  2. Assessment of tolerability on a 4-point scale [ Time Frame: 8 days after drug administration ]
  3. Change in lung function measurements airway resistance (Raw) [ Time Frame: up to 5 hours after drug administration ]
  4. Change in lung function measurement specific conductance (SGaw) [ Time Frame: up to 5 hours after drug administration ]
  5. Change in lunf function measurement forced expiratory volume in 1 second (FEV1) [ Time Frame: up to 5 hours after drug administration ]

Secondary Outcome Measures :
  1. Cmax (Maximum measured concentration of the analyte in plasma) [ Time Frame: up to 48 hours after drug administration ]
  2. tmax (Time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 48 hours after drug administration ]
  3. AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 48 hours after drug administration ]
  4. 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) [ Time Frame: up to 48 hours after drug administration ]
  5. λz (Terminal rate constant in plasma) [ Time Frame: up to 48 hours after drug administration ]
  6. t½ (Terminal half-life of the analyte in plasma) [ Time Frame: up to 48 hours after drug administration ]
  7. MRTih (Mean residence time of the analyte in the body after inhalation) [ Time Frame: up to 48 hours after drug administration ]
  8. CL/F (Apparent clearance of the analyte in plasma following extravascular administration) [ Time Frame: up to 48 hours after drug administration ]
  9. Vz/F (Apparent volume of distribution of the analyte during the terminal phase) [ Time Frame: up to 48 hours after drug administration ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
  • Blood donation (≥100 mL within 4 weeks prior to administration of investigational drug or during the trial)
  • Excessive physical activities (within the last week before the study)
  • Any laboratory value outside the reference range and of clinical relevance
  • For female subjects:

    • Pregnancy
    • Positive pregnancy test
    • No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device
    • Inability to maintain this adequate contraception during the whole study period,
    • Lactation period

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02199860     History of Changes
Other Study ID Numbers: 1149.44
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014