Oral semaglutide pharmacokinetics, effect of dosing schedules

• Research type

  Research Study

• Full title

  Oral semaglutide pharmacokinetics in healthy subjects, effect of dosing schedules

• IRAS ID

  281651

• Contact name

  Pablo ForteSoto

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2019-004569-42

• Clinicaltrials.gov Identifier

  U1111-1243-9641, WHO Universal Trial Number (UTN)

• Duration of Study in the UK

  0 years, 6 months, 11 days

• Research summary

  This trial is a randomised, single-centre, multiple-dose, open-label, five-armed, parallel group trial in 156 healthy male and female participants.

  The main purpose of the trial is to investigate the effect of different dosing schedules and timing of meals on the pharmacokinetic properties of oral semaglutide. Pharmacokinetics refers to how the drug is taken up into and distributed throughout the body; broken down and finally removed from the body.

  All participants will receive 1 semaglutide tablet daily for a total of 10 days. For the first 5 days, semaglutide tablets of 3 mg will be administered and for the next 5 days, semaglutide tablets of 7 mg will be given. Semaglutide (3 mg and 7 mg) will be administered under one of the 5 following dosing conditions.

  Arm A: 2-hour fast before dosing and 30 minutes fast after dosing
  Arm B: 4-hour fast before dosing and 30 minutes fast after dosing
  Arm C: 6-hour fast before dosing and 30 minutes fast after dosing
  Arm D: 2-hour fast before bedtime-dosing and overnight fast after bedtime dosing
  Arm E: overnight fast before dosing and 30 minutes fast after dosing (reference arm)

  26 participants each will be included in Arms A to D and 52 participants in Arm E that reflects the current dosing recommendations.

  The trial comprises a screening period of up to 28 days, an in-house stay of about 12 days and a follow-up period of at least 35 days after the last dose.

  Semaglutide has been developed by NovoNordisk A/S for the treatment of type 2 diabetes, and doses of 7 and 14 mg have already been granted marketing approval in Europe and the US. To enhance uptake by the body, the semaglutide tablet formulation has been co-formulated with the small fatty acid-derivative absorption enhancer SNAC (sodium N-(8-[2-hydroxybenzoyl] amino) caprylate.
  

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  20/SC/0163

• Date of REC Opinion

  6 Aug 2020

• REC opinion

  Further Information Favourable Opinion