Dose Extension Study of BIIX 1 XX in Healthy Young Male Volunteers

NCT ID: NCT02198287

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31

Brief Summary

Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.

Conditions

Healthy

Study Design

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

Study Groups

BIIX 1 XX, rising doses

Group Type: EXPERIMENTAL

BIIX 1 XX inhalation solution

Intervention Type: DRUG

single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BIIX 1 XX inhalation solution

single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males, based on a complete medical examination
• Age range from 21 to 50 years
• Participant must be within +/- 20 % of their normal weight (Broca-Index)
• Participant must provide written informed consent

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) or laboratory tests deviating from 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 then 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 two months prior to start of the study
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• 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

1150.7

Identifier Type: -

Identifier Source: org_study_id