A Two-Part Controlled Study of Single and Multiple Oral Doses of GM 1020 in Patients with MDD

• Research type

  Research Study

• Full title

  A Two-Part Controlled Clinical Study to Evaluate Safety, Tolerability, Response, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of GM-1020 in Patients with Major Depressive Disorder.

• IRAS ID

  1008321

• Contact name

  Jason Winters

• Contact email

  Jason@gilgameshpharmaceutical.com

• Sponsor organisation

  Gilgamesh Pharmaceuticals

• Eudract number

  2023-000724-11

• Research summary

  The purpose of this study is to test and investigational (unapproved) drug called GM-1020 (study drug) that is being developed for the treatment of Major Depressive Disorder (MDD).
  GM-1020 is a structural analogue of arketamine and it is hypothesised to be highly efficacious and rapid-acting antidepressant with limited side effects. The aim of the study is the explore whether a sub-dissociative exposure of the study drug produces a rapid and durable antidepressant effect in patients with MDD.

  The study will enrol up to 30 MDD patients across 5 non-NHS clinical trial units. Participants will attend the clinical unit for screening and if eligible, will be enrolled into Part A where they will be randomised to either a single oral dose of GM-1020 (140 mg) or a single oral dose of placebo on Day 1 and will switch to the opposite treatment arm on Day 15. Each participant will receive a single oral dose of 140 mg GM-1020 and a single oral dose of placebo in Part A.
  They will then undergo washout and on Day 29 will be randomised in Part B to one of two oral doses (140 mg or 210 mg) of GM-1020 taken twice-weekly for 2 weeks. After Day 42, participants will be followed up until Day 67.

  Study procedures will include blood sampling for assessment of PK and safety, ECG, vital signs, rsEEG; in addition, participants will be required to complete a number of questionnaires and scales to assess their mental and physiological state throughout the study.

  The estimates duration of participation is approximately 14 weeks from screening to final follow-up.

• REC name

  Wales REC 1

• REC reference

  23/WA/0228

• Date of REC Opinion

  8 Nov 2023

• REC opinion

  Further Information Favourable Opinion