Single Increasing Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Male Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BIIR 561 CL

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)
• Alcohol use of more than 60 g per day
• Drug dependency
• Excessive physical activities (e.g. competitive sports) within the last week before the study
• Blood donation within the last 4 weeks (>= 100 ml)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BIIR 561 CL	Drug: BIIR 561 CL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events		up to 8 days after drug administration
Number of subjects with clinically significant findings in vital functions	blood pressure, pulse rate, respiratory rate, oral body temperature	up to 8 days after drug administration
Number of subjects with clinically significant findings in ECG		up to 8 days after drug administration
Number of subjects with clinically significant findings in laboratory tests		up to 8 days after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 1999
• Primary Completion (Actual): June 1, 2000

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 600.2