Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448890
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2007-03-15
Brief Title:
Evaluation of Single and Repeat Doses of GSK729327 in Healthy Volunteers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Single-Blind Randomised Placebo-Controlled Two-Part Study to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single Oral Escalating Doses and Repeat Doses of GSK729327 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 025 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None