A Phase 1 Double-blind, Randomised, Placebo Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of S1-221 Following Oral Administration
Abstract
The purpose of this Phase 1 study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of single ascending doses of S1-221 administered orally to healthy adult participants. S1-221 is a liquid containing cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC).
Acute subjective effects will be evaluated as a pharmacodynamic (PD) assessment and changes in plasma endocannabinoid levels will be assessed as an exploratory objective.
Data from this study will be used to select doses to be evaluated in subsequent studies to investigate the efficacy and safety of S1-221 in migraine patients.
Conditions: Healthy Participants.
Primary outcome: Percentage of participants with treatment-emergent Adverse Events (AE). An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration.; Percentage of participants with treatment-emergent abuse-related Adverse Events (AE). An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration.; Percentage of participants with out-of-range red blood cell count (cells/µL).; Percentage of participants with out-of-range haematocrit (L/L).; Percentage of participants with out-of-range haemoglobin (g/L).; Percentage of participants with out-of-range white blood cell count including differential count (neutrophils, eosinophils, basophils, monocytes, and lymphocytes) (cells/µL).; Percentage of participants with…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 64 participants or records.
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