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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

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

SD I

SD II

Placebo

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

SD I - single rising doses

SD II - single rising doses

SD II - single rising doses + Placebo

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with adverse events

Assessment of tolerability on a 4-point scale

Change in lung function measurements airway resistance (Raw)

Change in lung function measurement specific conductance (SGaw)

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

Secondary Outcome Measures

Cmax (Maximum measured concentration of the analyte in plasma)

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

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

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)

λz (Terminal rate constant in plasma)

t½ (Terminal half-life of the analyte in plasma)

MRTih (Mean residence time of the analyte in the body after inhalation)

CL/F (Apparent clearance of the analyte in plasma following extravascular administration)

Vz/F (Apparent volume of distribution of the analyte during the terminal phase)

Full Information

NCT ID

NCT02199860

First Posted

July 24, 2014

Last Updated

July 24, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02199860

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

February 2004 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SD I - single rising doses

Arm Type

Experimental

Arm Title

SD II - single rising doses

Arm Type

Experimental

Arm Title

SD II - single rising doses + Placebo

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

SD I

Intervention Type

Drug

Intervention Name(s)

SD II

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Number of patients with adverse events

Time Frame

up to 25 days

Title

Assessment of tolerability on a 4-point scale

Time Frame

8 days after drug administration

Title

Change in lung function measurements airway resistance (Raw)

Time Frame

up to 5 hours after drug administration

Title

Change in lung function measurement specific conductance (SGaw)

Time Frame

up to 5 hours after drug administration

Title

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

Time Frame

up to 5 hours after drug administration

Secondary Outcome Measure Information:

Title

Cmax (Maximum measured concentration of the analyte in plasma)

Time Frame