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First Time in Human Study (FTIH) With Positron Emission Tomography (PET)

NCT01381419 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-07-07

No results posted yet for this study

Summary

This study described in the present protocol consists of two sections. Part A is the first administration into man to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of GSK1144814. The study is a single-blind, randomised, placebo-controlled design in healthy male and female (of non-childbearing potential) subjects. Part B will be an open-label design in healthy male subjects to assess the GSK1144814 neurokinin-1 (NK1) receptor occupancy by positron emission tomography (PET) scanning with \[11C\]-GR205171

Conditions

Interventions

DRUG

GSK1144814

Single dose.

DRUG

GSK1144814

Single dose which may be split in up to three divided doses given 2 to 3 hours apart.

DRUG

GSK1144814

Single dose that may be split in up to three divided doses given 2 to 3 hours apart.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-20
Primary Completion
2009-04-01
Completion
2009-04-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01381419 on ClinicalTrials.gov