Track topics on Twitter Track topics that are important to you
This is an open-label, single dose, randomized, five-period, crossover study in healthy volunteers to assess the relative bioavailability of four GSK developed oral formulations of GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb, PROTECT-1 Study and ChemoCentryx Thorough QT/QTc Study.
Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the five formulations of GSK1605786 after a standard breakfast. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The relative bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx formulation while the relative bioavailability the three other formulations will be compared to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study.
This will be a randomized, open-label, single-dose, five-period, crossover study in healthy volunteers to compare the relative bioavailability of 5 oral GSK1605786 formulations. Recruitment/screening will occur within approximately 30 days of the first scheduled dose of study medication. Each subject will participate in five dosing sessions - each dose will be separated by at least seven days. The total duration of a subject's participation in the study, from Screening to Follow-up, is approximately 10 weeks.
All subjects will receive single 500mg doses of the following five GSK1605786 formulations: A. ChemoCentryx formulation of GSK1605786; 2 x 250mg capsules [Formulation A] B. GSK formulation of GSK1605786; 2 x 250mg capsules [Formulation B] C. GSK direct-fill formulation of GSK1605786; 2 x 250mg capsules [Formulation C] D. GSK modified formulation of GSK1605786; 2 x 250mg capsules [Formulation D] E. GSK tablet formulation of GSK1605786; 500mg tablet [Formulation E]
Formulations A and B will administered in periods 1 and 2 in a random order, and formulations C, D and E will be administered in periods 3, 4, and 5 in a random order.
Subjects will check into the clinical research unit (CRU) 1 day prior to dosing (Day -1). The study medication will be administered in the morning of Day 1 with 240 mL of water 30 minutes after a standard breakfast (i.e., fed state). For each treatment period, subjects will stay in the CRU through the 48-hour PK sample on the morning of Day 3. Subjects may be released from the clinic on Day 3 (after all required study procedures are completed) and return to the CRU that evening and the next morning for collection of the 60- and 72-hour PK samples.
Upon completion of the last dosing period or early withdrawal, subjects will return to the clinic approximately seven days after the last dose of study medication for a follow up visit and be subsequently discharged from the study.
The study will be conducted at one center.
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
GSK1605786 formulation B, GSK1605786 formulation E, GSK1605786 formulation D, GSK1605786 formulation C, GSK1605786 formulation A
GSK Investigational Site
Published on BioPortfolio: 2014-08-27T03:14:01-0400
The purpose of this study is to evaluate in a double-blinded fashion the taste and overall acceptability profile of different ALS-008176 oral liquid formulations as compared to the referen...
The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new...
The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg
This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a s...
This review examines the use of predictive screening approaches in high concentration protein formulation development. In addition to the normal challenges associated with protein formulation developm...
Solithromycin is a fluoro-ketolide (a fourth-generation macrolide) antibiotic that has been undergoing clinical trials for the treatment of community acquired bacterial pneumonia. In this study, devel...
The objective of this work was to manufacture an enteric formulation of florfenicol (FF) using hot-melt extrusion (HME) technology and to evaluate its in vitro dissolution and in vivo pharmacokinetics...
The focus of this study is investigating the performance of graphene oxide (GO) in the protective effect of olive oil on Bacillus thuringiensis (Bt) after being exposed to UV radiations. Biological pe...
A type of viscous polysaccharide that is secreted from PLANTS. It has natural properties that are useful in the formulation of ADHESIVES.
A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.
Disorders in which phagocytic cells cannot kill ingested bacteria; characterized by frequent recurring infection with formulation of granulomas.
A field of biological research combining engineering in the formulation, design, and building (synthesis) of novel biological structures, functions, and systems.
Insulin formulation containing substance which delays or retards time period of the absorption of insulin.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...