Clinical trial NCT02269215: Single Increasing Doses of BIII 890 CL in Healthy Young Male Volunteers and in Healthy Elderly Male and Female Volunteers
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 73
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety, tolerability and pharmacokinetics of BIII 890


Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients with clinically relevant changes in vital signs
timeFrame: Pre-dose, up to 8 days after drug administration
measure: Number of subjects with clinically relevant changes in 12-lead ECG
timeFrame: Pre-dose, up to 8 days after drug administration
measure: Number of subjects with clinically relevant changes in laboratory parameters
timeFrame: Pre-dose, up to 8 days after drug administration
measure: Number of subjects with adverse events
timeFrame: Up to 8 days after drug administration
Secondary outcomes:
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 32 hours after start of drug administration
measure: Time from dosing to the maximum concentration of the analyte in plasma over a uniform dosing interval λz (tmax)
timeFrame: up to 32 hours after start of drug administration
measure: Apparent terminal half-life of the analyte in plasma (t1/2)
timeFrame: up to 32 hours after start of drug administration
measure: Area under the concentration-time curve of the analyte in plasma (AUC)
timeFrame: up to 32 hours after start of drug administration
measure: Mean residence time (MRT)
timeFrame: up to 32 hours after start of drug administration
measure: Plasma clearance (CL)
timeFrame: up to 32 hours after start of drug administration
measure: Volume of distribution (V)
timeFrame: up to 32 hours after start of drug administration
measure: Amount of parent drug excreted into urine (Ae)
timeFrame: up to 32 hours after start of drug administration
Other outcomes:
Locations:
Study officials:
References: