Glossary

active disease - a disease state in which the associated symptoms are continuously present

acute disease - a disease state marked by a sudden onset and of short duration

amylose - a carbohydrate of the starch group

antagonist - a compound that binds to a receptor on a cell that does not evoke an active response and also, as a consequence, prevents response to an agonist

Body Mass Index (“BMI”) - the classification of overweight and obesity is based on the measurement of Body Mass Index. BMI = weight (in kilograms)/height (in metres) squared

chronic disease - disease characterised by extended duration and typically by slow development or slow recurrence

clinically obese - a patient with a Body Mass Index (BMI) greater than 30 (or, in Japan, with a BMI in excess of 25)

colon - that part of the large intestine extending from the caecum to the rectum

co-morbidities - co-existing or additional diseases or conditions with reference to an existing disease or condition

constipation - the condition in which bowel movements are delayed or inadequate, resulting in undue retention of faeces in the colon

cytokine - a cell-signalling chemical

development - sub-divided into pre-clinical and clinical, this is the process by which a compound discovered in research is progressed into and through clinical trials to approval for marketing

diabetes - a range of conditions characterised by high blood sugar and glucose intolerance

diarrhoea - abnormal faecal discharge characterised by frequent and/or watery stool

EMEA - European Medicines Agency: responsible for overseeing the approval process for drugs to be marketed in the European Union

enzyme - a protein that catalyses a chemical reaction

fat - organic compounds formed by ester bonds between three molecules of fatty acids and one molecule of glycerol, used by the body for energy storage

FDA - the United States Food and Drug Administration: responsible for overseeing the approval process for a new drug or device to be marketed in the US

gastrointestinal tract - the oesophagus, the stomach and the intestines

GCP - Good Clinical Practice: an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects

GI - gastrointestinal

GMP - Good Manufacturing Practice: an international quality standard for the manufacture of drugs

haemoglobin - a protein contained in red blood cells, which transports oxygen around the body

HbA_1c - a ‘glycosylated haemoglobin’ formed when glucose attaches to the haemoglobin

IND - application to FDA to perform clinical trials with an investigational new drug

indication - disease patient population targeted

insulin - a hormone that controls the amount of sugar in the blood

insulin resistance - the body's inability to respond to and use the insulin it produces

lipase - an enzyme that catalyses the breakdown of fat

lipase inhibitor - a substance that blocks the action of a lipase enzyme

MAA - Marketing Authorisation Application

MHRA - Medicines and Healthcare products Regulatory Agency: responsible for overseeing the approval process for a new drug or device to be marketed in the UK (except drugs whose approval process is overseen by the EMEA)

morbidity - degree of sickness

mucositis - inflammation of the mucous membranes that line certain hollow organs of the body, e.g. the mouth and gastrointestinal tract, which is a common side effect of cancer chemotherapy

NDA - New drug application; an application to FDA for approval to market a drug in the US

obesity - a state of excess body weight: a patient with a BMI in excess of 30 is considered clinically obese (or, in Japan, a BMI in excess of 25)

oesophagus - the tube that connects the pharynx to the stomach

OTC - over the counter; a medicine that can be obtained without a prescription

pharmacodynamics - a drug’s action in the body over time

pharmacokinetics - absorption, distribution, metabolism and excretion of drugs

pharynx - the part of the digestive tract that connects the mouth to the oesophagus

Phase I - the first trials in humans that test a compound for safety, tolerability and pharmacokinetics. These trials usually employ normal healthy volunteers and comprise Phase Ia and Phase Ib trials

Phase Ia - the first part of a Phase I trial testing a compound for safety, tolerability and pharmacokinetics following a single dose

Phase Ib - the second part of a Phase I trial testing a compound for safety, tolerability and pharmacokinetics following repeat dosing

Phase II - early efficacy and safety trials conducted in limited numbers of patients. They include dose-ranging studies to establish an appropriate range of doses in patients

Phase IIa - a clinical trial involving the administration of a drug to human beings in which the primary objective is to obtain a preliminary evaluation of the efficacy of the drug in patients

Phase IIb - a clinical trial involving the administration of a drug to human beings in which the primary objective is to establish the appropriate doses in patients

Phase III - a clinical trial of a drug in patients involving the form, dose and indication of the drug which is intended to be marketed, in which the primary objective is to obtain clinical and statistical significant evidence of efficacy, and confirmation of safety and tolerability in patients

pre-clinical development - development activities prior to testing in humans including pilot manufacture, toxicology and metabolism studies

prednisolone - an anti-inflammatory steroid

programme - a course of action whose objective is to develop drugs against a specific molecular target which is thought to contribute to a particular disease mechanism

SPA - Special Protocol Assessment

steroids - a class of drugs used to treat a number of diseases including inflammatory diseases such as ulcerative colitis

stomach - the organ below the oesophagus where food is stored while it is broken down by acid and digestive enzymes

sugar - any monosaccharide or smaller oligosaccharide

systemic - throughout the whole body

TNF - tumour necrosis factor: a cytokine that can induce necrosis (death) of tumour cells and possess a wide range of proinflammatory actions

type 2 diabetes - a form of diabetes primarily characterised by insulin resistance and relative insulin deficiency

UC - ulcerative colitis: a chronic inflammatory disease of the colon and/or rectum

WHO - World Health Organisation