Evaluation of the Pharmacokinetics and Safety of Rivastigmine Intranasal Spray

Phase 1

Completed

• Conditions: Alzheimer's disease; Neurological - Alzheimer's disease

• Registration Number: ACTRN12614001313628
• Lead Sponsor: achesis Biosciences Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Healthy Caucasian males and females between 55 and 85 years (inclusive) of age.
- No known history of clinically significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, haematopoietic disease, neoplasm or any other clinically significant medical disorder, which in the Principal Investigator's judgment contraindicate administration of the study interventions.
- BMI 18-32 (inclusive) calculated as Weight (Kg)/Height (sq.m).

Exclusion Criteria

- Known hypersensitivity to the drug, components (benzyl alcohol, benzoates) or other carbamates.
- Current symptomatic allergic rhinitis
- History of or currently active asthma or chronic obstructive pulmonary disease, excluding childhood asthma.
- History of or currently active cardiac arrhythmias such as bradycardia and sick sinus syndrome.
- History of urinary tract obstruction.
- History of or currently active GI diseases such as peptic ulcer, GERD, bleeding or history of any GI surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence drug absorption, or with any history of anorexia, frequent nausea or emesis, regardless of etiology.
- Use of any beta-blocker class prescription drug, cholinomimetic and anticholinergic drugs, including atropine, tricyclic antidepressants and anti-histamines.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: F, Cmax, tmax, AUC0-infinity, t1/2, Cavg<br><br>Plasma assay for rivastigmine and its' primary metabolite (NAP 226-90) and pharmacokinetic parameters calculated using noncompartmental pharmacokinetic analysis.[Nasal: Pre-dose, 5, 10, 15, 30, 60, 90 mins; 2, 3, 4, 6, 8, 10, 12 and 24 h<br>IV: Pre-dose, 10, 20, 30, 45, 60, 75, 90 mins; 2, 3, 4, 6, 8, 12 and 24 h]