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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BIIX 1 XX inhalation solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02198287

1150.7

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

BIIX 1 XX, rising doses

Experimental group

Treatment:

Drug: BIIX 1 XX inhalation solution

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo