Status and phase
Conditions
Treatments
About
This is a first time in human (FTIH) study to evaluate the safety, tolerability and pharmacokinetics (PK) of single and repeat ascending doses of GSK2556286 in healthy adult participants. Food effect (FE) cohorts will investigate the influence of food on the PK of GSK2556286. The study will be conducted in two parts. Part A will be a single ascending dose (SAD) including up to 11 cohorts (Cohort 1A to cohort 11A) and Part B will be a multiple ascending dose (MAD), including up to 4 cohorts (Cohort 1B to cohort 4B).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Significant history of or current, cardiovascular, respiratory (including asthma), hepatic, renal, gastrointestinal, endocrine, hematological, infectious or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs: constituting a risk when taking part in the study or interfering with the interpretation of data.
Alanine aminotransferase (ALT) greater than (>)1.5 times upper limit of normal (ULN).
Total bilirubin >1.5 times ULN (isolated total bilirubin >1.5 times ULN may be acceptable, after consultation with the GlaxoSmithKline (GSK) Medical Monitor, if total bilirubin is fractionated and direct bilirubin less than [<]35 percent [%]).
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or cholecystectomy.
Current or past history of significant renal disease including renal stones.
Current or past history of gastroduodenal ulcers or persistent gastritis requiring medication.
Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.
Exclusion criteria for screening electrocardiogram (ECG) with:
Evidence of previous myocardial infarction (does not include ST segment changes associated with re-polarization).
Any clinically significant conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular [AV] block [second degree or higher], Wolff -Parkinson-White [WPW] syndrome).
Sinus Pauses >3 seconds.
Any significant arrhythmia which, in the opinion of the Investigator or GSK Medical monitor, will interfere with the safety for the individual participant.
Non-sustained or sustained ventricular tachycardia (3 consecutive ventricular ectopic beats).
Evidence of latent tuberculosis documented by:
Use of prescription or non-prescription drugs, including Nonsteroidal anti-inflammatory drugs (NSAIDs), high-dose vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Cotinine in urine indicative of smoking or history or regular use of tobacco or nicotine-containing products within 3 months.
Current regular alcohol consumption defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 milliliters [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
A positive test for Human immunodeficiency virus (HIV) antibody.
Urinary analysis indicating presence of blood, protein or glucose. If trace or 1 plus (+) is found on urine dipstick, a repeat test can be performed. If repeat is positive, participant is excluded from recruitment.
Screening age-appropriate estimated glomerular filtration rate (eGFR) <90 milliliters per minute mL/min as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Serum (and in the MAD, urinary) electrolytes outside of normal range. May be repeated once if abnormal.
A positive pre-study drug/alcohol screen.
The participant has taken part in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Part A (Food Effect) Cohort: Participant must have no relevant dietary restrictions (lactose intolerance) or inability to eat a high fat meal.
Primary purpose
Allocation
Interventional model
Masking
120 participants in 4 patient groups, including a placebo group
Loading...
Central trial contact
EU GSK Clinical Trials Call Center; US GSK Clinical Trials Call Center
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal