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

NCT ID: NCT02198313

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIIX 1 XX - D1

Group Type: EXPERIMENTAL

BIIX 1 XX - D1

Intervention Type: DRUG

BIIX 1 XX - D2

Group Type: EXPERIMENTAL

BIIX 1 XX - D2

Intervention Type: DRUG

BIIX 1 XX - D3

Group Type: EXPERIMENTAL

BIIX 1 XX - D3

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BIIX 1 XX - D1

Intervention Type: DRUG

BIIX 1 XX - D2

Intervention Type: DRUG

BIIX 1 XX - D3

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male volunteers who have Broca-Indices within +-20%
• Participants in the age range between 21 to 50 years

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1150.3

Identifier Type: -

Identifier Source: org_study_id