Randomized, double-blind, placebo-controlled, 3-way cross-over study to characterize the pharmacodynamics and pharmacokinetics of single-dose intravenously administered biperiden in healthy elderly male and female subjects

Centre for Human Drug Research0 sites12 target enrollmentAugust 2, 2022

ConditionsImproving the cognitive impairment associated with dementia and other neurocognitive disorders Nervous System Diseases

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Improving the cognitive impairment associated with dementia and other neurocognitive disorders
Sponsor: Centre for Human Drug Research
Enrollment: 12
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 2, 2022

End Date

August 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Centre for Human Drug Research

Eligibility Criteria

Inclusion Criteria

•1\. Elderly male or female subjects aged between 65 and 80 (inclusive) years old
•2\. Healthy subjects as defined by the absence of evidence of any clinically relevant active or chronic disease following detailed medical and surgical history review and a complete physical examination including vital signs,12\-lead ECG, haematology, blood chemistry, and urinalysis
•3\. Absence of cognitive impairment evident by a score of 28 or higher on the Mini\-Mental State Examination (MMSE)

Exclusion Criteria

•1\. Clinically relevant history of abnormal physical or mental health interfering with the study as determined from the medical history review and the physical examinations obtained during the screening visit and/or at the start of the first study day for each period as judged by the investigator (including (but not limited to), neurological (including myasthenia gravis, epilepsy and tardive dyskinesia), cardiovascular (including current hypertension, orthostatic hypotension and recent myocardial infarction), respiratory, gastrointestinal (including previous ileus or megacolon and past or current gastro\-intestinal stenosis), hepatic, renal, urogenital (including urinary retention or prostate hypertrophy) disorder or presence of narrow\-angle glaucoma).
•2\. Current or history of any clinically relevant psychiatric disorder as classified according to DSM\-IV or DSM 5 (e.g. psychotic disorder e.g. schizophrenia/schizo\-affective disorder, bipolar disorder Type I or Type II, personality disorder, major depressive disorder/persistent depressive disorder, obsessive\-compulsive disorder, panic disorder, anorexia nervosa, bulimia nervosa, generalized anxiety disorder (GAD), post\-traumatic stress disorder (PTSD), autism spectrum disorder (ASD)sleep disorders and previous delirium).
•3\. Any disease associated with cognitive impairment.
•4\. History of severe allergies, or history of an anaphylactic reaction to prescription or non\-prescription drugs or food.
•5\. History of hypersensitivity to biperiden or to the excipients used in the biperiden formulation.
•6\. Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
•7\. Positive urine drug screen (UDS), or alcohol breath test at screening and/or upon admission to the Clinical Research Unit (CRU).
•8\. Presence or history (within 3 months of screening) of alcohol abuse confirmed by medical history, or daily alcohol consumption exceeding 2 standard drinks per day on average for females or exceeding 3 standard drinks per day on average for males (1 standard drink \= 10 grams of alcohol), and the inability to refrain from alcohol during the visits until discharge from the CRU (alcohol consumption will be prohibited during study confinement).
•9\. Use of tobacco and/or nicotine\-containing products within 90 days of dosing and throughout the study until follow\-up.
•10\. Excessive caffeine consumption, defined as \>800 mg per day from 7 days prior to the first dose of the study drug until 24 hours prior to dosing. Subjects will abstain from caffeine\-containing products for 24 hours prior each dosing and whilst in the study unit until discharge from the study unit. At other times throughout the study, subjects should not consume more than 800 mg caffeine per day. Caffeine quantities defined as: one cup of coffee contains 100 mg of caffeine; one cup of tea, or one glass of cola, or potion of chocolate (dark: 100 g, milk 200 g) contains approximately 40 mg of caffeine; one bottle of Red Bull contains approximately 80 mg of caffeine.