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

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02268136
• Other study ID #: 599.1
• Status: Terminated
• Phase: Phase 1
• First received: October 16, 2014
• Last updated: October 16, 2014
• Start date: April 1999

Study information

• Verified date: October 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. primary completion date: December 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BIII 890 CL

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with clinically relevant changes in vital signs		up to 8 days after drug administration	No
Primary	Number of subjects with adverse events		up to 8 days after drug administration	No
Primary	Number of subjects with clinically relevant changes in electrocardiogram		up to 8 days after drug administration	No
Primary	Number of subjects with clinically relevant changes in pharmaco electroencephalogram (EEG)		up to 24 hours after drug administration	No
Primary	Number of subjects with clinically relevant changes in laboratory parameters		up to 8 days after drug administration	No
Secondary	Maximum plasma concentration (Cmax)		up to 24 hours after drug administration	No
Secondary	Time to reach Cmax (tmax)		up to 24 hours after drug administration	No
Secondary	Terminal half-life (t1/2)		up to 24 hours after drug administration	No
Secondary	Area under the plasma concentration-time curve (AUC) for several time points		up to 24 hours after drug administration	No
Secondary	Mean residence time (MRT)		up to 24 hours after drug administration	No
Secondary	Plasma clearance (CL)		up to 24 hours after drug administration	No
Secondary	Volume of distribution (Vz)		up to 24 hours after drug administration	No
Secondary	Amount of the analyte excreted in urine (Ae)		up to 24 hours after drug administration	No

External Links

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