Examining the pharmacokinetic and pharmacodynamic profile of biperide

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant has a body mass index of 18.5-30 kg/m2, inclusive, at medical screening.
• The participant is aged 18 to 35 years, inclusive, at the time of informed consent.
• The volunteer is healthy, i.e. absence of all exclusion criteria and had normal or corrected to normal static binocular acuity with or without correction.
• The participant signs and dates a written informed consent form before the start of the experiments.
• The participant has sufficient knowledge of the English language.

Exclusion Criteria

• The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results.
• The volunteer has uncontrolled existing major psychiatric symptoms.
• The participant has known hypersensitivity to any component of the formulation or biperiden or related compounds.
• The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the first visit or is unwilling to agree to abstain from alcohol from 24 hours prior to each test day and/or drugs throughout the study.
• The participant has any sensory or motor deficits which could reasonably be expected to affect test performance.
• Other exclusion criteria are smoking, excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of medication other than oral contraceptives.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the main endpoints for the cognitive tasks are the behavioural scores on the<br /><br>immediate and delayed recall of the VLT. This includes the number of words<br /><br>recalled immediately and after a 20-minute delay.<br /><br><br /><br>Amendment:<br /><br>The main endpoints for the attention tasks are the behavioral score on<br /><br>Alerting, Orienting and Executive Network (ANT), endogenous and exogenous<br /><br>attention (VCT), and recognition of deep encoded, shallowly encoded and novel<br /><br>stimuli (BUNM).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To establish the pharmacokinetic and pharmacodynamic profile of biperiden, the<br /><br>primary endpoints will be the blood serum values and physiological measures<br /><br>(body temperature, blood pressure, heart rate and pupil size). Furthermore the<br /><br>behavioural outcomes of the n-back, DAT, and simple and choice reaction tasks<br /><br>will be used for analysis, as well as the score on the B&L and complaints<br /><br>questionnaire. Next to this, the event-related potentials during the<br /><br>behavioural tasks will be analysed. Another important measure is the brain<br /><br>response to the novelty oddball task, which will give an indication of the role<br /><br>of acetylcholine in novelty processing.<br /><br><br /><br><br /><br>Amendment:<br /><br>We will analyze the scores on general attention (VCT) the B&L and complaints<br /><br>questionnaire. Next to this, the event-related potentials during the<br /><br>behavioural tasks will be analyzed.</p><br>