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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIII 890 CL; Drug: Placebo

• Registration Number: NCT02269215
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Safety, tolerability and pharmacokinetics of BIII 890

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2000-09
• Status Verified: 2014-10
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-20
• Last Update Submitted: 2014-10-20
• Study First Posted: 2014-10-21
• Last Update Posted: 2014-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIII 890 CL single rising dose	BIII 890 CL	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximum measured concentration of the analyte in plasma (Cmax)	up to 32 hours after start of drug administration
Apparent terminal half-life of the analyte in plasma (t1/2)	up to 32 hours after start of drug administration
Volume of distribution (V)	up to 32 hours after start of drug administration
Mean residence time (MRT)	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
Area under the concentration-time curve of the analyte in plasma (AUC)	up to 32 hours after start of drug administration
Plasma clearance (CL)	up to 32 hours after start of drug administration
Amount of parent drug excreted into urine (Ae)	up to 32 hours after start of drug administration