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CompletedNCT02199860Updated Jul 25, 2014

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

A Phase 1 interventional study of SD I and SD II in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-25.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 215 are open to participants now.

This study's enrollment of 63 is above the median of 43 across 882 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
63 participants (actual)

Study arms

  • 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

Interventions

  • DrugSD I
  • DrugSD II
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02199860
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 25, 2014
Start date
May 2003
Primary completion
Feb 2004
Last update
Jul 25, 2014
View the source record on ClinicalTrials.gov ↗

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