CompletedPhase 1

A Study to Look at How GSK1325756 is Taken up by the Body When Given by Mouth When Stomach Acid is Reduced

United Kingdom20 participantsStarted 2011-10-12

Plain-language summary

This is a Phase I study to assess the combined effects of food and suppression of gastric acid secretion on the relative bioavailability of an immediate release (IR) tablet formulation and prototype bioenhanced formulations of GSK1325756, an oral interleukin 8 receptor (IL8R also known as CXCR2) antagonist. The objectives are to understand if the co-administration of food enhances absorption and the inter-subject variability for the current GSK1325756 IR tablet under fed state proton pump inhibitor (PPI) conditions and secondly to assess whether two proposed bioenhanced formulations offer any improvement over the current GSK1325756 IR formulation under PPI conditions. This open-label, randomized, 5-period crossover study will be completed in a single cohort of subjects, with an interim analysis after completion of Treatment Period 4. During Treatment Periods 1 to 4, subjects will be randomized to receive GSK1325756 50 mg IR in the fed state, GSK1325756 50 mg IR in the fasted state, GSK1325756 Bioenhanced Formulation 1 in the fasted state, and GSK1325756 Bioenhanced Formulation 2 in the fasted state. Progression to Treatment Period 5 and the choice of bioenhanced formulation for dosing in this treatment period will be dependent on the findings of an interim analysis of the pharmacokinetic profile and relative bioavailability of each formulation following completion of Treatment Periods 1 to 4. In Treatment Period 5, subjects will receive the selected GSK1325756 bioenhanced formulation in the fed state.

Who can participate

Age range65 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or non-childbearing potential female who, at the time of signing the informed consent, are aged between 65 and 80 years (inclusive). Non-childbearing potential is defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone \[FSH\] greater than 40 milli-international units per milliliter MlU/mL) and estradiol less than 40 picograms per milliliter (pg/mL) \[less than 147 picomoles per liter (pmol/L)\] is confirmatory). * Healthy, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator and the GlaxoSmithKline (GSK) Medical Monitor agree that the finding is unlikely to introduce risk factors and will not interfere with the study procedures and objectives. * Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase and bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) (isolated bilirubin greater than 1.5 times the ULN is acceptable if bilirubin is fractionated and direct bilirubin is less than 35 percent (%)). * Resting blood pressure of less than or equ…

What they're measuring

Pharmacokinetics

Timeframe: Forty eight hour period following dose

Trial details

NCT IDNCT01453478

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-12-19