HTL0018318 Single & Multiple dose PK, Safety study in Healthy Subjects
Research type
Research Study
Full title
A two-part, single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
IRAS ID
226557
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Heptares Therapeutics Limited
Eudract number
2017-001245-27
Duration of Study in the UK
0 years, 3 months, 4 days
Research summary
We are conducting a study of drug HTL0018318 in healthy adult Caucasian and Japanese volunteers. HTL0018318 is an experimental product under development by Heptares Therapeutics Ltd to be used in the prevention or treatment of Alzheimer’s disease. This drug is being developed as a potential equivalent or superior symptomatic treatment to existing therapies, but with a better side-effect profile.
Single and multiple ascending (increasing) dose studies in healthy young and elderly adults, have been performed. This study aims to compare the safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian volunteers. Data will be compared within study and to previous HTL0018318 study data in order to be able to start trials in Japanese patients.
Fifty-four healthy subjects will be recruited into the study. This study consists of two parts, each part consisting of a screening phase (up to 27 days), two treatment periods separated by a washout period and a follow-up visit post-final dose.
In Part A, 24 volunteers (12 Caucasian:12 Japanese) will be given a single dose of 15mg of HTL0018318 in Period 1 (P1) and a single dose of 25mg HTL0018318 in P2, separated by a washout period of 10 days, with a follow-up 7-10 days post final dose.
In Part B, 30 volunteers (15 Caucasian:15 Japanese)will be randomly assigned to a once daily dosing regimen of 5 days and will receive HTL0018318 15mg or placebo in Period 1 and HTL0018318 25mg or placebo in Period 2, separated by a washout period of 14 days, with a follow-up 11-14 days post-final dose.
We will collect blood and urine samples for pharmacokinetic measurements and assess safety parameters including physical examination, vital sign measurements, laboratory evaluations, electrocardiogram (ECG), respiratory function and monitoring of adverse events (AEs).REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/0602
Date of REC Opinion
28 Apr 2017
REC opinion
Favourable Opinion