Back to resultsA Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX in Healthy Male Volunteers
Primary Purpose
Healthy
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BIIX 1 XX - D1
BIIX 1 XX - D2
BIIX 1 XX - D3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- Healthy male volunteers who have Broca-Indices within +-20%
- Participants in the age range between 21 to 50 years
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study. Subsequently each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)
- Haematopoietic, hepatic and renal function test will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Exclusion Criteria:
- Any finding of the medical examination (including blood pressure, pulse rate or ECG) or laboratory tests deviating form normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of a drug with a long half-life (>= 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
- Participation in another trial with an investigational drug within the last two months prior to the start of the study
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- History of alcohol abuse and/or alcohol abuse
- Drug abuse
- Blood donation (>100 ml) within four weeks prior to administration
- Other disease or abnormality of clinical relevance
- Excessive physical activities within two weeks prior to administration or during the trial
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
BIIX 1 XX - D1
BIIX 1 XX - D2
BIIX 1 XX - D3
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of subjects with adverse events
Number of subjects with abnormal changes in laboratory parameters
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Number of subjects with clinically significant changes in ECG (Electrocardiogram)
Secondary Outcome Measures
AUC (Total Area under the plasma drug concentration time curve)
Cmax (maximum observed concentration of the analyte in plasma)
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
t½ (Terminal half-life of the analyte in plasma)
MRT (mean time of residence of drug molecules in the body )
CL (Total clearance of the analyte in plasma following extravascular administration)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02198313
Brief Title
A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX in Healthy Male Volunteers
Official Title
A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX (100 µg, 200 µg, 400 µg b.i.d. for 14 Days ) in Healthy Male Volunteers (Randomised, Double-blind Within Each Dose Group, Placebo-controlled, Parallel-group)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
April 1999 (undefined)
Primary Completion Date
April 1999 (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 objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data
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
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIIX 1 XX - D1
Arm Type
Experimental
Arm Title
BIIX 1 XX - D2
Arm Type
Experimental
Arm Title
BIIX 1 XX - D3
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BIIX 1 XX - D1
Intervention Type
Drug
Intervention Name(s)
BIIX 1 XX - D2
Intervention Type
Drug
Intervention Name(s)
BIIX 1 XX - D3
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of subjects with adverse events
Time Frame
up to day 28
Title
Number of subjects with abnormal changes in laboratory parameters
Time Frame
up to day 21
Title
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Time Frame
up to day 21
Title
Number of subjects with clinically significant changes in ECG (Electrocardiogram)
Time Frame
up to 21 days
Secondary Outcome Measure Information:
Title
AUC (Total Area under the plasma drug concentration time curve)
Time Frame
up to 336 hours after last drug administration
Title
Cmax (maximum observed concentration of the analyte in plasma)
Time Frame
up to 336 hours after last drug administration
Title
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time Frame
up to 336 hours after last drug administration
Title
t½ (Terminal half-life of the analyte in plasma)
Time Frame
up to 336 hours after last drug administration
Title
MRT (mean time of residence of drug molecules in the body )
Time Frame
up to 336 hours after last drug administration
Title
CL (Total clearance of the analyte in plasma following extravascular administration)
Time Frame
up to 336 hours after last drug administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male volunteers who have Broca-Indices within +-20%
Participants in the age range between 21 to 50 years
In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study. Subsequently each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)
Haematopoietic, hepatic and renal function test will be carried out in the laboratory
The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Exclusion Criteria:
Any finding of the medical examination (including blood pressure, pulse rate or ECG) or laboratory tests deviating form normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
History of orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Intake of a drug with a long half-life (>= 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
Participation in another trial with an investigational drug within the last two months prior to the start of the study
Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
Inability to refrain from smoking on study days
History of alcohol abuse and/or alcohol abuse
Drug abuse
Blood donation (>100 ml) within four weeks prior to administration
Other disease or abnormality of clinical relevance
Excessive physical activities within two weeks prior to administration or during the trial
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
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A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX in Healthy Male Volunteers
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