A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX in Healthy Male Volunteers

Healthy Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02198313
• Other study ID #: 1150.3
• Status: Terminated
• Phase: Phase 1
• Start date: April 1999

Study information

• Verified date: August 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. primary completion date: April 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BIIX 1 XX - D1

• BIIX 1 XX - D2

• BIIX 1 XX - D3

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		up to day 28
Primary	Number of subjects with abnormal changes in laboratory parameters		up to day 21
Primary	Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)		up to day 21
Primary	Number of subjects with clinically significant changes in ECG (Electrocardiogram)		up to 21 days
Secondary	AUC (Total Area under the plasma drug concentration time curve)		up to 336 hours after last drug administration
Secondary	Cmax (maximum observed concentration of the analyte in plasma)		up to 336 hours after last drug administration
Secondary	tmax (Time from dosing to the maximum concentration of the analyte in plasma)		up to 336 hours after last drug administration
Secondary	t½ (Terminal half-life of the analyte in plasma)		up to 336 hours after last drug administration
Secondary	MRT (mean time of residence of drug molecules in the body )		up to 336 hours after last drug administration
Secondary	CL (Total clearance of the analyte in plasma following extravascular administration)		up to 336 hours after last drug administration

External Links

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