Single Increasing Doses of BIII 890 CL in Healthy Young Male Volunteers and in Healthy Elderly Male and Female Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIII 890 CL

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02269215

599.2

Details and patient eligibility

About

Safety, tolerability and pharmacokinetics of BIII 890

Enrollment

73 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants in the study should be healthy males, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index) and healthy elderly males and females, > 60 years of age and be within +-25 % of their normal weight (Broca-Index)
In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion criteria

Volunteers were excluded from the study if the results of the medical examination, laboratory tests or ECG recordings are judged by the 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), central nervous system (CNS) trauma in their medical history or with psychiatric disorders or neurological disorders
Volunteers with known history of relevant orthostatic hypotension, fainting spells or blackouts
Volunteers with chronic or relevant acute infections
Volunteers with history of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as, judged by the investigator
Volunteers who had taken 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
Volunteers who received any other drugs which could influence the results of the trial during the week prior to the start of the study
Volunteers who participated in another study with an investigational drug within the last two months preceding this study
Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
Volunteers who were not able to refrain from smoking on study days
Volunteers who drunk more than 60 g of alcohol per day
Volunteers who were dependent on drugs
Volunteers who participated in excessive physical activities (e.g. competitive sports) during the last week before the study
Volunteers who donated blood within the last 4 weeks (≥ 100 mL)