SAD/MAD Study with OP352 in Healthy Younger Adult and Elderly Participants

• Research type

  Research Study

• Full title

  Controlled Study to Assess Safety, Tolerability and Pharmacokinteic Profile of Ascending Single and Multiple Doses of OP-352 in Healthy Younger Adult and Elderly Participants, and to Evaluate Effect of Food on Pharmacokinetic Profile of OP-352

• IRAS ID

  268869

• Contact name

  Muna Albayaty

• Contact email

  muna.albayaty@parexel.com

• Sponsor organisation

  Outpost Medicine (OPM2 Ltd)

• Eudract number

  2019-002540-25

• Duration of Study in the UK

  0 years, 10 months, 15 days

• Research summary

  The main purpose of the study is to:\n- Look at side effects of the study drug (changes in the body that are not intended \n and unwanted) after a single dose and after 2 weeks of doses. \n- Look at the blood levels of the drug and how quickly the body gets rid of it.\n- Look at both side effects and blood levels of the study drug in different groups \n of people (non-Japanese, Japanese and elderly).\n- Look to see if food affects blood levels of the drug and how quickly the body gets \n rid of it.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  19/LO/1155

• Date of REC Opinion

  10 Aug 2019

• REC opinion

  Further Information Favourable Opinion