Evaluation of Biomarkers of Drug-induced Acute Pancreatitis

• Research type

  Research Study

• Full title

  Prospective Evaluation of Novel Biomarkers of Drug-induced Acute Pancreatitis (AP) in Healthy Subjects

• IRAS ID

  273729

• Contact name

  Samuel Israel

• Sponsor organisation

  Eli Lilly Cork Limited

• Clinicaltrials.gov Identifier

  19/NE/0320 , REC Ref

• Duration of Study in the UK

  0 years, 1 months, 24 days

• Research summary

  MicroRNA (miRNA) are a new class of blood markers to aid in the diagnosis of diseases, this study will be helping in developing new markers for drug induced pancreatic injury (DIPI). To aid in developing a good marker, this study will be evaluating how the pancreas (organ that is involved in digestion and maintaining glucose levels in the blood) causes these markers to be released into the blood with meals in healthy people so they can gather information on the variability of these markers in healthy people after meals. This will aid in developing a new miRNA marker by understanding baseline values and variabilities in healthy people we will be able to understand levels of these markers in early pancreatic injury.

  Up to 60 subjects may be enrolled. Up to 17 subjects aged 21 to 50, inclusive (Group 1), up to 30 subjects aged >50 to 65, inclusive (Group 2), and up to 15 subjects >65 years old (Group 3).

  Subjects will be admitted to the clinical research unit (CRU) on Day 1 following an overnight fast. They will have an initial set of blood tests within 15 min before their meal. Subjects will then be provided with a liquid meal (eg, Slim Fast ®) and a meal bar (eg, Clif Bar®) and will have blood samples taken 2hrs after the meal. Subjects will be discharged from the CRU on Day 1 following all study assessments at the discretion of the investigator.

• REC name

  North East - York Research Ethics Committee

• REC reference

  19/NE/0320

• Date of REC Opinion

  13 Dec 2019

• REC opinion

  Favourable Opinion