Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female Volunteers

NCT02223507 | Completed Phase 1

• 1 other identifier: 600.6
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events

  up to 8 days after drug administration

• Number of subjects with clinically significant findings in vital functions

  blood pressure, pulse rate, respiratory rate, oral body temperature

  up to 8 days after drug administration

• Number of subjects with clinically significant findings in ECG

  up to 8 days after drug administration

• Number of subjects with clinically significant findings in laboratory tests

  up to 8 days after drug administration

Secondary Outcomes (10)

• Maximum drug plasma concentration (Cmax)

  up to 32 hours after first drug administration

• Time to Cmax (tmax)

  up to 32 hours after first drug administration

• Terminal half-life (t1/2)

  up to 32 hours after first drug administration

• Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)

  up to 32 hours after first drug administration

• Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)

  up to 32 hours after first drug administration

Study Arms (2)

BIIR 561 CL

EXPERIMENTAL

Drug: BIIR 561 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIR 561 CL DRUG

BIIR 561 CL

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

irampanel

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: August 1, 2000
• Primary Completion: September 1, 2000
• Last Updated: August 22, 2014

Record last verified: 2014-08