GlaxoSmithKline

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Evaluating a Heart Magnetic Resonance Imaging (MRI) Procedure and the Effect of Fish Oil Supplementation in People Who Have Recently Had a Heart Attack (The PROSPECT-CMR Study)

Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the body. This study will evaluate a new MRI technique in people who have recently had a heart attack. Researchers will also examine the effect of fish oil supplementation on heart health in study participants.

Background information
Other unique IDs: 
591
1 R01 HL091157-01A1

Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.

Background information
Other unique IDs: 
444563/005

A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.

Trial phase: 
Phase I
Recruitment status: 
Completed

Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess the effect of hight fat food on the PK of the 100mg capsule. The study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There will be a week wash out between each dose. In the three dosing periods subjects will either received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14 days after the final dose. It is expected that the total duration of the study should be approximately eight weeks.

Background information
Trial ID: 
NCT00728897
Other unique IDs: 
DAN111283
Official title: 

An Open Label, Randomised, Single Dose, Three-Way Crossover Study to Investigate the Relative Bioavailability of a 100mg Capsule Compared to Four 25mg GSK598809 Capsules and the Effect of Food on the Pharmacokinetics of the 100mg Capsule in Healthy Male a

Detailed description: 

 

Number to be enrolled: 
16 patients

GSK372475 PK Study in Healthy Volunteers

This study will consist of 4 parallel cohorts of healthy volunteers(elderly male, elderly female, young male and young female. Subjects will receive either GSK372475 1.5mg or placebo for 28 days

Background information
Other unique IDs: 
105467

A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers.

Trial phase: 
Phase I
Recruitment status: 
Completed

Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. The study is planned to consist of a single part, with 4 dosing periods. Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at least 1 week of wash out between doses. In each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. The actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. It is expected that the duration of this study will be approximately 10 weeks.

Background information
Trial ID: 
NCT00728052
Other unique IDs: 
DAN111282
Official title: 

A Placebo-Controlled, Single-Blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses (75mg and Above) of GSK598809 in Otherwise Healthy Volunteers.

Detailed description: 

 

Number to be enrolled: 
1 patients

A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT

Trial phase: 
Phase III
Recruitment status: 
Recruiting

The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.

Background information
Trial ID: 
NCT00727597
Other unique IDs: 
COL 110408
Official title: 

A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT

Detailed description: 

The objective of this study is to gain tolerability and efficacy data for Norvir-boosted Lexiva versus Sustiva, both used in combination with Epzicom, as components of a first-line, once daily regimen for the treatment of HIV-1 infection in a patient population that is underrepresented in US clinical research.

Number to be enrolled: 
100 patients
Acronym: 
SUPPoRT

Immunogenicity and Safety of GSK Biologicals' FluLaval® TF

The present study is intended to assess a novel formulation of FluLaval. The idea is to obtain preliminary data on the safety and immune response to the FluLaval TF influenza vaccine in adults. These data will serve as a basis for further studies involving different populations. This protocol posting deals with objectives & outcome measures of the primary phase/study.

Background information
Other unique IDs: 
112219

GSK1349572 Drug Interaction With Tenofovir

A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and tenofovir

Background information
Other unique IDs: 
111604

A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)

Trial phase: 
Phase II
Recruitment status: 
Recruiting

This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.

Background information
Trial ID: 
NCT00726323
Other unique IDs: 
MET111644
Official title: 

A Phase 2 Study of the c-Met RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Papillary Renal-Cell Carcinoma

Detailed description: 

 

Number to be enrolled: 
71 patients

Phase 2 Study of GSK1363089 (Formerly XL880) in Adults With Squamous Cell Cancer of the Head and Neck

Trial phase: 
Phase II
Recruitment status: 
Recruiting

This study is being conducted to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor tyrosine kinases (RTKs) with growth-promoting and angiogenic properties. The primary targets of GSK1363089 are the HGF and vascular endothelial growth factor (VEGF) RTK families (eg, MET, VEGFR2/kinase insert domain receptor [KDR]). Since MET overexpression has been associated with poor prognosis and MET tyrosine kinase mutations have been reported in SCCHN, inhibition of MET receptor and VEGFR2/KDR activation by agents such as GSK1363089 may be of therapeutic benefit in this patient population.

Background information
Trial ID: 
NCT00725764
Other unique IDs: 
MET111646
Official title: 

A Phase 2 Study of the MET RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

Detailed description: 

 

Number to be enrolled: 
41 patients
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