A Single-blind, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 37.5 mg/h - 150 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 20 mg/h - 40 to 125 mg/h), Infusion Time 5 Hours

Boehringer Ingelheim0 sites60 target enrollmentNovember 1999

ConditionsHealthy

InterventionsBIIR 561 CL Placebo

Overview

Phase: Phase 1
Intervention: BIIR 561 CL
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 60
Primary Endpoint: Number of subjects with clinically significant findings in ECG
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 is to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing doses in healthy young volunteers

Registry

clinicaltrials.gov

Start Date

November 1999

End Date

June 2000

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male volunteers
•Age 21 to 50 years
•Broca index from -20% to +20%
•Written informed consent prior to admission to the study

Exclusion Criteria

•Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values
•Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
•Known diseases of the central nervous system (CNS) (such as epilepsy), CNS trauma in their medical history or with psychiatric or neurological disorders
•Known 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 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
•Intake of any other drug which might influence the results of the trial during 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)

Arms & Interventions

BIIR 561 CL

Intervention: BIIR 561 CL

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of subjects with clinically significant findings in ECG

Time Frame: up to 8 days after drug administration

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 laboratory tests

Time Frame: up to 8 days after drug administration

Secondary Outcomes

Maximum concentration in plasma (Cmax)(up to 32 hours after first drug administration)
Time to maximum concentration in plasma (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)
Total Mean residence time (MRTtot)(up to 32 hours after first drug administration)
Total plasma clearance (CLtot)(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)
Amount excreted into urine (Ae)(up to 32 hours after first drug administration)
Mean residence time of disposition (MRTdisp)(up to 32 hours after first drug administration)
Renal clearance (CLR)(up to 32 hours after first drug administration)