Phase 1 Pilocarpine effect study on Salivary Secretion & Pupillometry
Research type
Research Study
Full title
A Phase 1 Study to Investigate the Effect of Oral Doses of Pilocarpine on Salivary Secretion and Static Pupillometry in Healthy Subjects
IRAS ID
171196
Contact name
Annelize Koch
Contact email
Sponsor organisation
Astellas
Eudract number
2014-004753-13
Duration of Study in the UK
0 years, 2 months, 14 days
Research summary
The model tested in this study is based on the use of a medicine called pilocarpine (referred to as the “study drug”). Pilocarpine is used to treat patients with reduced salivary (spit) flow. The Sponsor is testing the study drug to see if it may be used as an experimental model in future studies, to test the effectiveness of newly developed medicines.
The main purpose of the study is to investigate the effect of the study drug on salivary secretion. The study will also investigate the effect of the study drug on pupil (the black part in the centre of the eye) diameter. The effects (salivary secretion and pupil dilation) that the study drug has on the body is called pharmacodynamics (PD) of the study drug. The study will also try to determine how safe the study drug is and how well it is tolerated after dosing. In addition, the study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted this is called the pharmacokinetics (PK) of the study drug.
This study will recruit healthy, non-smoking, males and females between the ages of 18 and 55 years (inclusive). A total of 12 subjects will take part in the study.
Vital signs, safety ECG measurements, safety laboratory assessments, saliva samples, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic analysis will be collected.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0096
Date of REC Opinion
12 Mar 2015
REC opinion
Further Information Favourable Opinion