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

Phase 1

Terminated

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

• Registration Number: NCT02268136
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-04
• Primary Completion: 1999-12
• Status Verified: 2014-10
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-16
• Last Update Submitted: 2014-10-16
• Study First Posted: 2014-10-20
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 76

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIII 890 CL	BIII 890 CL	single increasing doses
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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
Number of subjects with clinically relevant changes in vital signs	up to 8 days after drug administration
Number of subjects with adverse events	up to 8 days after drug administration

Secondary Outcome Measures

Name	Time	Method
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