HTL0018318 and donepezil interaction study in elderly volunteers.
Completed
- Conditions
- Drug-Drug interaction, M1 agonist, Alzheimer, donepezil
- Registration Number
- NL-OMON28309
- Lead Sponsor
- Heptares Therapeutics Ltd.
- Brief Summary
ot applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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 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;
Exclusion Criteria
Subjects must meet none of the following exclusion criteria at screening:
1. Legal incapacity or inability to understand or comply with the requirements of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability / safety endpoints<br /><br> Treatment-emergent (serious) adverse events ((S)AEs)<br /><br> Concomitant medication<br /><br> Clinical laboratory tests<br /><br>o Haematology<br /><br>o Chemistry<br /><br>o Urinalysis<br /><br> Vital signs<br /><br>o Pulse Rate (bpm)<br /><br>o Systolic blood pressure (mmHg)<br /><br>o Diastolic blood pressure (mmHg)<br /><br> Electrocardiogram (ECG)<br /><br>o Heart Rate (HR) (bpm), PR, QRS, QT, QTcF<br /><br> Holter 24 hours. <br /><br>PK
- Secondary Outcome Measures
Name Time Method Pharmacodynamic endpoints<br /><br> Visual Analog Scales (VAS) according to Bond and Lader to assess:<br /><br>o mood (mm)<br /><br>o alertness (mm)<br /><br>o calmness (mm)<br /><br> VAS nausea (mm)<br /><br> Salivary measurement (g)<br /><br> Respiratory function<br /><br>o Forced vital capacity (FVC)<br /><br>o Volume forcedly expired in 1 second (FEV1)<br /><br>o Peak Expiratory Flow (PEF) in litres per second<br /><br> Leeds Sleep Evaluation Questionnaire (LSEQ):<br /><br>o Getting to sleep (GTS) (mm)<br /><br>o Quality of sleep (QOS) (mm)<br /><br>o Awake following sleep (AFS) (mm)<br /><br>o Behaviour following wakening (BFW) (mm)<br /><br> Assessment of heart rate variability