Evaluation of Single and Repeat Doses of GSK729327 in Healthy Volunteers
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
GSK729327 is a selective positive allosteric modulator of AMPA-type ionotropic glutamate
receptors, exhibiting equivalent potency at all AMPA receptor subtypes. On the basis of
preclinical studies it is expected that this compound will improve cognitive measures in
schizophrenic patients with acceptable safety. This is a First Time in Human Study (FTIH) to
assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of
GSK729327 in healthy volunteers. The study will be conducted in 2 parts, with single doses
being explored in Part A and multiple doses over 28 days in Part B. Part A will be a single
blind, placebo controlled, single oral dose, dose-rising cross-over study in healthy male
volunteers. Subjects will be randomized into two cohorts with an alternate panel design.
There will be up to nine dosing sessions in total in order to investigate up to 7 different
doses. The initial dose will be 0.25 mg and subsequent doses will be determined based on the
pharmacokinetic and safety results from the previous dose. Part B will be a randomised,
single blind, placebo-controlled, parallel group study of repeat oral dosing of GSK729327. Up
to 4 cohorts of 15 (12 subjects receiving active dose and 3 subjects receiving placebo)
healthy male and females of (non-childbearing potential) volunteers will be enrolled in Part
B.