This project tests the safety, tolerability, pharmacokinetics (PK, the amount of study drug in your blood) and pharmacodynamics (PD, how the study drug affects your body) of single doses of KUR-101 in 58 healthy participants.
This is a Phase I trial from atai Life Sciences. KUR-101 is an oral formulation of mitragynine, an alkaloid derived from the kratom plant. atai hopes that KUR-101 will effectively treat opioid use disorder (OUD) patients.
Topic Opioid Use Disorder
Compound Kratom
Country United States of America
Visit trial
Status
Recruiting
Results Published
No
Start date
15 February 2022
End date
31 October 2022
Chance of happening
100%
Phase
Phase I
Design
Blinded
Type
Interventional
Generation
Second
Participants
58
Sex
All
Age
18- 65
Therapy
No
Trial Details
This study is divided into two parts: Part 1 is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, PK, analgesic and respiratory effects of single ascending doses of orally administered KUR-101 in normal healthy participants. Once the MTD has been determined, this dose, or an alternate lower dose, will be taken into Part 2 of the study. This part will involve a single ascending (increasing) dose (SAD) where 40 participants (5 groups of 8) will be randomised (assigned randomly, like flipping a coin) to receive a single oral dose of the study drug or placebo. Part 2 is a randomized, double-blind, placebo-controlled, three-period crossover study to assess the analgesic and respiratory effects of a single oral KUR-101 as compared to that of oxycodone in normal healthy participants. This part will involve a crossover design where 18 participants will be randomised to receive a single oral dose of each of three interventions (study drug, placebo or a marketed form of oxycodone). Each dose is separated by 7 days and the participants are randomised so they do not know the order of the interventions.NCT Number NCT05114265
Sponsors & Collaborators
atai Life Sciencesatai Life Sciences is one of the biggest companies in the psychedelics field. The company aims to be a platform and has nine subsidiary companies working on everything from psilocybin for depression to DMT administration.