*Pritelivir's effect on ECG of healthy subjects: a thorough QT/QTc trial

• Research type

  Research Study

• Full title

  A double-blind, single-center, randomized, placebo- and positive-controlled, parallel-group trial with a nested crossover part on the electrocardiographic effects of 100 and 400 mg Pritelivir per day in healthy subjects: a thorough QT/QTc trial

• IRAS ID

  1005590

• Contact name

  Silvia Riffel-Friedrich

• Contact email

  silvia.riffel-friedrich@aicuris.com

• Sponsor organisation

  AiCuris Anti-infective Cures AG

• Eudract number

  2022-000203-12

• Clinicaltrials.gov Identifier

  NCT05671029

• Research summary

  Richmond Pharmacology are conducting a clinical trial aimed at investigating the ECG effects of Pritelivir in healthy subjects. Pritelivir is an investigational drug intended for use in the treatment of Herpes simplex virus (HSV) infection. It is active against both strains of HSV (HSV-1 and HSV-2). HSV is typically transmitted via oral-to-oral contact thus causing infection in or around the mouth (oral herpes), but it can also cause infections around the genitals (genital herpes). Pritelivir works by preventing the production of virus deoxyribonucleic acid (DNA) thus stopping the growth of HSV.

  This clinical trial will involve 64 healthy male and female volunteers aged between 18 and 45 years of any ethnic origin who will be recruited into 2 groups (Group 1 and Group2). It will take approximately 58 days to complete, including the time before the clinical trial to determine eligibility to participate, the conduct of the clinical trial (comprising of an in-house period of 22 days/21 nights) and follow-up examinations at the end of the clinical trial. Participants will be discharged on Day 20. The in-house stay may be extended if necessary for safety.
  
  The main aims of this clinical trial are as follows:
  • To determine the effect of Pritelivir on the electrical activity of the heart which is also referred to as pharmacodynamics
  • To determine how Pritelivir is absorbed, distributed, broken down and excreted by the body when multiple tablets are swallowed. This process is called Pharmacokinetics.
  • To evaluate other impacts Pritelivir can have on the heart
  • To determine the effect of Moxifloxacin on the heart
  • To determine how safe and tolerable Pritelivir is when swallowed

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  22/LO/0411

• Date of REC Opinion

  29 Nov 2022

• REC opinion

  Further Information Favourable Opinion