Clinical trial NCT02223507: Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female Volunteers
Official title: A Single-blind, Placebo-controlled Single Dose Tolerance Study in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 75 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 40 mg/h and 75 mg/h, Infusion Time 5 Hours)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 13
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two increasing doses in healthy elderly volunteers, following the infusion schema of a loading dose (1 hour) and a maintenance dose (5 hours)


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers
* Age \>= 60 years
* Broca index from -25% to +25%
* Written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (exclusion: substitution therapy regarding thyroid gland and/or ovaries)
* Diseases of the central nervous system (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders and medical history of such diseases or disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs 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
* Intake of any drugs which might influence the results of the trial (\<= one week prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 30g/day for males, \> 24 g for females)
* Drug abuse
* Blood donation (\>= 100 ml within four weeks prior to administration or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range of clinical relevance

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 8 days after drug administration
measure: Number of subjects with clinically significant findings in vital functions
timeFrame: up to 8 days after drug administration
measure: Number of subjects with clinically significant findings in ECG
timeFrame: up to 8 days after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 8 days after drug administration
Secondary outcomes:
measure: Maximum drug plasma concentration (Cmax)
timeFrame: up to 32 hours after first drug administration
measure: Time to Cmax (tmax)
timeFrame: up to 32 hours after first drug administration
measure: Terminal half-life (t1/2)
timeFrame: up to 32 hours after first drug administration
measure: Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)
timeFrame: up to 32 hours after first drug administration
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)
timeFrame: up to 32 hours after first drug administration
measure: Mean residence time (MRT)
timeFrame: up to 32 hours after first drug administration
measure: Plasma clearance (CL)
timeFrame: up to 32 hours after first drug administration
measure: Volume of distribution (Vz)
timeFrame: up to 32 hours after first drug administration
measure: Volume of distribution at steady state (Vss)
timeFrame: up to 32 hours after first drug administration
measure: Amount excreted into urine (Ae)
timeFrame: up to 32 hours after first drug administration
Other outcomes:
Locations:
Study officials:
References: