Single Increasing Doses of BIII 890 CL in Healthy Young M... | NCT02269215

NCT02269215

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
BIII 890 CL single rising dose	Experimental		Drug: BIII 890 CL
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BIII 890 CL	Drug		BIII 890 CL single rising dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with clinically relevant changes in vital signs	blood pressure, pulse rate, respiratory rate, body temperature	Pre-dose, up to 8 days after drug administration
Number of subjects with clinically relevant changes in 12-lead ECG		Pre-dose, up to 8 days after drug administration
Number of subjects with clinically relevant changes in laboratory parameters	including coagulation parameters	Pre-dose, up to 8 days after drug administration
Number of subjects with adverse events		Up to 8 days after drug administration

Secondary Outcomes

Measure	Description	Time Frame
Maximum measured concentration of the analyte in plasma (Cmax)		up to 32 hours after start of drug administration
Time from dosing to the maximum concentration of the analyte in plasma over a uniform dosing interval λz (tmax)		up to 32 hours after start of drug administration

Eligibility Module

Eligibility Criteria

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)