Safety, Tolerability and Pharmacodynamics of BIIX 1 XX in Healthy Young Male Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIIX 1 XX - single rising dose

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02199873

1150.1

Details and patient eligibility

About

The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data

Enrollment

24 patients

Sex

Male

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male volunteers who have Broca-Indices within +-20%
Participants in the age range between 21 to 50 years
Following the methacholine challenge the airway resistance (Raw) shows an increase of at least 130%
In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
As part of the screening (within 14 days before drug administration), 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

Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Volunteers with diseases of the central nervous system (such as epilepsy) or with 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 one month before enrolment in the study
Use of any drugs which might influence the results of the trial the week previous to the start of the study
Participation in another study with an investigational drug within the last two months preceding this study
Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
Inability to refrain from smoking on study days
Alcohol abuse (> 60g/day)
Drug abuse
Blood donation within the last 4 weeks
Excessive physical activities within the last week before the study