A Single-blind, Placebo-controlled Single Dose Tolerance Study in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 75 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 40 mg/h and 75 mg/h, Infusion Time 5 Hours)

Boehringer Ingelheim0 sites13 target enrollmentAugust 2000

ConditionsHealthy

InterventionsBIIR 561 CL Placebo

DrugsBIIR 561 CL Placebo

Overview

Phase: Phase 1
Intervention: BIIR 561 CL
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 13
Primary Endpoint: Number of subjects with adverse events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two increasing doses in healthy elderly volunteers, following the infusion schema of a loading dose (1 hour) and a maintenance dose (5 hours)

Registry

clinicaltrials.gov

Start Date

August 2000

End Date

September 2000

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and female volunteers
•Age \>= 60 years
•Broca index from -25% to +25%
•Written informed consent prior to admission to the study

Exclusion Criteria

•Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
•Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (exclusion: substitution therapy regarding thyroid gland and/or ovaries)
•Diseases of the central nervous system (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders and medical history of such diseases or disorders
•History of orthostatic hypotension, fainting spells or blackouts
•Chronic or relevant acute infections
•Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
•Intake of drugs 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
•Intake of any drugs which might influence the results of the trial (\<= one week prior to administration or during the trial)
•Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial
•Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)

Arms & Interventions

BIIR 561 CL

Intervention: BIIR 561 CL

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of subjects with adverse events

Time Frame: up to 8 days after drug administration

Number of subjects with clinically significant findings in vital functions

Time Frame: up to 8 days after drug administration

blood pressure, pulse rate, respiratory rate, oral body temperature

Number of subjects with clinically significant findings in ECG

Time Frame: up to 8 days after drug administration

Number of subjects with clinically significant findings in laboratory tests

Time Frame: up to 8 days after drug administration

Secondary Outcomes

Mean residence time (MRT)(up to 32 hours after first drug administration)
Plasma clearance (CL)(up to 32 hours after first drug administration)
Volume of distribution (Vz)(up to 32 hours after first drug administration)
Volume of distribution at steady state (Vss)(up to 32 hours after first drug administration)
Maximum drug plasma concentration (Cmax)(up to 32 hours after first drug administration)
Time to Cmax (tmax)(up to 32 hours after first drug administration)
Terminal half-life (t1/2)(up to 32 hours after first drug administration)
Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)(up to 32 hours after first drug administration)
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)(up to 32 hours after first drug administration)
Amount excreted into urine (Ae)(up to 32 hours after first drug administration)