Single Increasing Doses of BIII 890 CL in Healthy Young Male Volunteers and in Healthy Elderly Male and Female Volunteers

A Single Blind, Placebo-controlled, Parallel-group, Single Increasing Dose Tolerance Study in Healthy Young Male Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 12.5, 25, 50 mg/h, Infusion Time 1 hr; 50 mg/h, Infusion Time 2 Hrs) Followed by Maintenance Dose (Dosage: 6.25, 12.5, 25 mg/h, Infusion Time 5 Hrs; 30 mg/h, Infusion Time 4 Hrs) and in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 50 mg/h, Infusion Time 1 hr) Followed by Maintenance Dose (Dosage: 25 mg/h, Infusion Time 5 Hrs)

Safety, tolerability and pharmacokinetics of BIII 890

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants in the study should be healthy males, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index) and healthy elderly males and females, > 60 years of age and be within +-25 % of their normal weight (Broca-Index)
• In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

• Volunteers were excluded from the study if the results of the medical examination, laboratory tests or ECG recordings are judged by the investigator to differ significantly from normal clinical values
• Volunteers with 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 (CNS) trauma in their medical history or with psychiatric disorders or neurological disorders
• Volunteers with known history of relevant orthostatic hypotension, fainting spells or blackouts
• Volunteers with chronic or relevant acute infections
• Volunteers with history of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as, judged by the investigator
• Volunteers who had taken 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
• Volunteers who received any other drugs which could influence the results of the trial during the week prior to the start of the study
• Volunteers who participated in another study with an investigational drug within the last two months preceding this study
• Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
• Volunteers who were not able to refrain from smoking on study days
• Volunteers who drunk more than 60 g of alcohol per day
• Volunteers who were dependent on drugs
• Volunteers who participated in excessive physical activities (e.g. competitive sports) during the last week before the study
• Volunteers who donated blood 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: BIII 890 CL single rising dose	Drug: BIII 890 CL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with clinically relevant changes in vital signs	blood pressure, pulse rate, respiratory rate, body temperature	Pre-dose, up to 8 days after drug administration
Number of subjects with clinically relevant changes in 12-lead ECG		Pre-dose, up to 8 days after drug administration
Number of subjects with clinically relevant changes in laboratory parameters	including coagulation parameters	Pre-dose, up to 8 days after drug administration
Number of subjects with adverse events		Up to 8 days after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum measured concentration of the analyte in plasma (Cmax)	up to 32 hours after start of drug administration
Time from dosing to the maximum concentration of the analyte in plasma over a uniform dosing interval λz (tmax)	up to 32 hours after start of drug administration
Apparent terminal half-life of the analyte in plasma (t1/2)	up to 32 hours after start of drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)	up to 32 hours after start of drug administration
Mean residence time (MRT)	up to 32 hours after start of drug administration
Plasma clearance (CL)	up to 32 hours after start of drug administration
Volume of distribution (V)	up to 32 hours after start of drug administration
Amount of parent drug excreted into urine (Ae)	up to 32 hours after start of drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): September 1, 2000

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 20, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 599.2