Increasing Dose Tolerance Study in Healthy Male Volunteers After Administration of BIII 890 CL

A Single-blind, Placebo-controlled, Parallel Group, Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIII 890 CL (Dosage: 0.5 mg/h - 80 mg/h), Infusion Time 1 Hour.

The objective ot the present study is to obtain information about safety, tolerability and preliminary pharmacokinetics of BIII 890 CL after single intravenous administration of increasing doses in healthy male volunteers.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BIII 890 CL

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects as determined by results of screening
• Age ≥ 21 and ≤ 50 years
• Broca index ≥ - 20% and ≤ + 20%
• Signed written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

• Results of the medical examination, laboratory tests or electrocardiogram recordings are judged by the clinical investigator to differ significantly from normal clinical values
• 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 trauma in the medical history or with psychiatric disorders or neurological disorders
• Known history of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of 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 the last month or less than ten half-lives of the respective drug before enrolment in the study
• Intake of any other drugs 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
• Smokers (> 10 cigarettes or 3 cigars or 3 pipes/day)
• Volunteers who are not able to refrain from smoking on study days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Participation in excessive physical activities (e.g. competitive sports) within the last week before the study
• Blood donation (≥ 100 ml) within the last 4 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo
EXPERIMENTAL: BIII 890 CL; single increasing doses	Drug: BIII 890 CL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events	up to 8 days after drug administration
Number of subjects with clinically relevant changes in vital signs	up to 8 days after drug administration
Number of subjects with clinically relevant changes in electrocardiogram	up to 8 days after drug administration
Number of subjects with clinically relevant changes in pharmaco electroencephalogram (EEG)	up to 24 hours after drug administration
Number of subjects with clinically relevant changes in laboratory parameters	up to 8 days after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax)	up to 24 hours after drug administration
Time to reach Cmax (tmax)	up to 24 hours after drug administration
Terminal half-life (t1/2)	up to 24 hours after drug administration
Area under the plasma concentration-time curve (AUC) for several time points	up to 24 hours after drug administration
Mean residence time (MRT)	up to 24 hours after drug administration
Plasma clearance (CL)	up to 24 hours after drug administration
Volume of distribution (Vz)	up to 24 hours after drug administration
Amount of the analyte excreted in urine (Ae)	up to 24 hours after drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (ACTUAL): December 1, 1999

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (ESTIMATE): October 20, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 16, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 599.1