Clinical trials: sponsored by GlaxoSmithKline
Drug Interactions, Neoplasms
A Cross-over Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics (PK) of GSK525762 in Healthy Female Subjects of Non Child Bearing Potential
This is a Phase I, single center, two-part, randomized, open label, cross-over study. Part 1 of this study will evaluate the PK, safety, and tolerability of GSK525762 when administered alone and when co-administered following…
- Trial name
- NCT02706535
- Testing
- GSK525762 Besylate Tablets, Itraconazole 200 mg, Rifampicin 300 mg
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infection, Fungal Infection
Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir
The purpose of this study is to determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers.A second objective is to determine the safety of combined use of…
- Trial name
- EPOS (NCT00817765)
- Testing
- Posaconazole, Fosamprenavir, Ritonavir
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Influenza, Human
Immunogenicity & Safety Study of Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years
This study is designed to test the safety and immunogenicity of Fluviral® (2009 - 2010 Season) in adults aged 18 to 60 years and over 60 years.
- Trial name
- NCT00929331
- Testing
- Fluviral®
- Where
- Canada
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate…
- Trial name
- NCT00985751
- Testing
- Pneumococcal vaccine GSK2189242A (formulation 1), Pneumococcal vaccine GSK2189242A (formulation 2), Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
- Where
- 10 sites in Czechia
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Myeloid Leukemia
Trial of Eltrombopag During Consolidation Therapy in Adults With AML in Complete Remission
Patients with Acute Myeloid Leukemia (AML) in complete remission will receive eltrombopag while undergoing consolidation chemotherapy with high-dose cytarabine.
- Trial name
- PrE0901 (NCT01656252)
- Testing
- Phase I- Cytarabine & Eltrombopag, Phase II- Sequence A, Phase II- Sequence B
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- PrECOG, LLC.
Malaria, Vivax
A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria
This is a prospective, open-label, multicenter, non-comparative, single arm study of pediatric subjects with Plasmodium vivax (P. vivax) malaria, aged 6 months to <16 years of age. A total of 60 subjects will be enrolled.
- Trial name
- NCT02563496
- Testing
- Tafenoquine, Chloroquine
- Where
- 4 sites in Colombia, Vietnam
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Fever, Neutropenia
Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting
The purpose of this study is to determine whether, in children with cancer presenting with fever in severe chemotherapy-induced neutropenia at low risk for medical complications, oral antibiotics in an outpatient setting after an…
- Conditions
- Fever, Neutropenia, Cancer
- Trial name
- NCT00107081
- Testing
- ciprofloxacin and amoxicillin, Outpatient management, i.v. antibiotics
- Where
- 12 sites in Germany, Netherlands and 1 more
- Volunteers
- 70 people
- Sponsor
- Swiss Pediatric Oncology Group
Epilepsy
Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
The purpose of this study is to evaluate the long-term safety and tolerability of retigabine/ezogabine as an adjunctive treatment in subjects with either partial onset seizures (12 to < 18 years old) or Lennox-Gastaut Syndrome…
- Trial name
- NCT01668654
- Testing
- retigabine/ezogabine
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus
A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects
The drug effects will be studied after a single dose of 50 milligram (mg) albiglutide and a single dose of 10 microgram exenatide, to gain insight into the central mechanisms of nausea associated with Glucagon-like peptide-1…
- Trial name
- NCT02802514
- Testing
- Albiglutide 50mg, Exenatide 10microgram
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV…
- Trial name
- NCT00947115
- Testing
- Blood sampling, Cervico-vaginal secretion (CVS) samples
- Where
- 6 sites in Germany, Poland
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus, Type 2
An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects
The primary objective of this study is to compare the effect of albiglutide and exenatide on gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by visual analogue scale [VAS]) in subjects with…
- Trial name
- NCT02793154
- Testing
- Exenatide, Albiglutide
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- GlaxoSmithKline
Graves Ophthalmopathy
A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease
The purpose of this study is to investigate the safety and tolerability of otelixizumab in patients with Graves' ophthalmopathy (thyroid eye disease).
- Trial name
- NCT01114503
- Testing
- Otelixizumab - low dose, Otelixizumab - medium low dose, Otelixizumab - medium high dose
- Where
- United Kingdom
- Volunteers
- 2 people
- Sponsor
- GlaxoSmithKline
Arthritis, Rheumatoid
Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid Arthritis
GSK3117391 has the potential to complement existing therapies in the treatment of chronic inflammatory disorders such as rheumatoid arthritis (RA).
- Trial name
- NCT02965599
- Testing
- GSK3117391
- Where
- 5 sites in Poland, Romania
- Volunteers
- 3 people
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus, Type 1
Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus
The purpose of this study to assess the safety and tolerability of re-dosing at 6 months with otelixizumab (given as an 8-day series of intravenous infusions) in adult subjects with newly diagnosed type 1 diabetes mellitus
- Trial name
- NCT01222078
- Testing
- otelixizumab
- Where
- 2 sites in France, Germany
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Colitis, Ulcerative
Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis
This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be contributing to the pathology of ulcerative colitis.
- Trial name
- NCT00748410
- Testing
- SB-656933
- Where
- Netherlands
- Volunteers
- 3 people
- Sponsor
- GlaxoSmithKline
Influenza, Influenza Vaccines
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.
- Trial name
- NCT01195779
- Testing
- GSK Bio's influenza vaccine GSK2584786A, different formulations, GSK Bio's influenza vaccine GSK2321138A, Fluarix™
- Where
- Spain
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 for the routine immunization of infants and children living in malaria endemic areas.
- Trial name
- NCT00289185
- Testing
- RTS,S/AS02D, Engerix-B®, TETRActHib™
- Where
- Tanzania
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs
For effective drug delivery using inhalation route, it is important to use the inhalers correctly. This open-label study will evaluate the error rates during the use of ELLIPTA DPI, alone or in combination, in comparison with…
- Trial name
- NCT03114969
- Testing
- Relvar ELLIPTA, Symbicort TURBUHALER, Seretide DISKUS
- Where
- 13 sites in Netherlands, United Kingdom
- Volunteers
- 450 people
- Sponsor
- GlaxoSmithKline
Asthma
Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma
This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25 mcg on lung function versus placebo after 24 weeks of treatment.
- Trial name
- NCT03012061
- Testing
- UMEC, Fluticasone Furoate, Albuterol/salbutamol
- Where
- 70 sites in United States, Canada and 3 more
- Volunteers
- 425 people
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/UMEC/VI [100/62.5/25 microgram (mcg)]…
- Trial name
- NCT03478683
- Testing
- budesonide/formoterol, albuterol/salbutamol, FF/UMEC/VI
- Where
- 57 sites in United States, Czechia and 2 more
- Volunteers
- 729 people
- Sponsor
- GlaxoSmithKline