This is a two-phase, randomized, double-blind, placebo-controlled, within-participant crossover study to assess the safety, tolerability, PK, and PD of five oral doses of CHI-915 versus placebo in healthy adult participants ages 18-55 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
21
THCv in MCT oil
Nucleus Network
Saint Paul, Minnesota, United States
Incidence, type and severity of AEs/SAEs
Incidence, type and severity of AEs/SAEs
Time frame: Day 1
Incidence, type and severity of AEs/SAEs
Incidence, type and severity of AEs/SAEs
Time frame: Day 8
Incidence, type and severity of AEs/SAEs
Incidence, type and severity of AEs/SAEs
Time frame: Day 15
Incidence, type and severity of AEs/SAEs
Incidence, type and severity of AEs/SAEs
Time frame: Day 22
Incidence, type and severity of AEs/SAEs
Incidence, type and severity of AEs/SAEs
Time frame: Day 29
Incidence, type and severity of AEs/SAEs
Incidence, type and severity of AEs/SAEs
Time frame: Day 36
Change in blood pressure
Change in systolic and diastolic blood pressure measured in mmHg
Time frame: Day 1
Change in heart rate
Change in heart rate measured in beats per minute
Time frame: Day 1
Change in respiratory rate
Change in respiratory rate measured in breaths per minute
Time frame: Day 1
Change in body temperature
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Change in body temperature measured in degrees Celsius
Time frame: Day 1
Change in blood pressure
Change in systolic and diastolic blood pressure measured in mmHg
Time frame: Day 8
Change in heart rate
Change in heart rate measured in beats per minute
Time frame: Day 8
Change in respiratory rate
Change in respiratory rate measured in breaths per minute
Time frame: Day 8
Change in body temperature
Change in body temperature measured in degrees Celsius
Time frame: Day 8
Change in blood pressure
Change in systolic and diastolic blood pressure measured in mmHg
Time frame: Day 15
Change in respiratory rate
Change in respiratory rate measured in breaths per minute
Time frame: Day 15
Change in heart rate
Change in heart rate measured in beats per minute
Time frame: Day 15
Change in body temperature
Change in body temperature measured in degrees Celsius
Time frame: Day 15
Change in blood pressure
Change in systolic and diastolic blood pressure measured in mmHg
Time frame: Day 22
Change in respiratory rate
Change in respiratory rate measured in breaths per minute
Time frame: Day 22
Change in heart rate
Change in heart rate measured in beats per minute
Time frame: Day 22
Change in body temperature
Change in body temperature measured in degrees Celsius
Time frame: Day 22
Change in blood pressure
Change in systolic and diastolic blood pressure measured in mmHg
Time frame: Day 29
Change in heart rate
Change in heart rate measured in beats per minute
Time frame: Day 29
Change in respiratory rate
Change in respiratory rate measured in breaths per minute
Time frame: Day 29
Change in body temperature
Change in body temperature measured in degrees Celsius
Time frame: Day 29
Change in blood pressure
Change in systolic and diastolic blood pressure measured in mmHg
Time frame: Day 36
Change in heart rate
Change in heart rate measured in beats per minute
Time frame: Day 36
Change in respiratory rate
Change in respiratory rate measured in breaths per minute
Time frame: Day 36
Change in body temperature
Change in body temperature measured in degrees Celsius
Time frame: Day 36
Change in ECG results
Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
Time frame: Day 1
Change in ECG results
Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
Time frame: Day 8
Change in ECG results
Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
Time frame: Day 15
Change in ECG results
Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
Time frame: Day 22
Change in ECG results
Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
Time frame: Day 29
Change in ECG results
Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
Time frame: Day 36
Maximum effect for the item "energetic" on the DEQ
Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"
Time frame: Day 1
Maximum effect for the item "energetic" on the DEQ
Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"
Time frame: Day 8
Maximum effect for the item "energetic" on the DEQ
Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"
Time frame: Day 15
Maximum effect for the item "energetic" on the DEQ
Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"
Time frame: Day 22
Maximum effect for the item "energetic" on the DEQ
Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"
Time frame: Day 29
Maximum effect for the item "energetic" on the DEQ
Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"
Time frame: Day 36
Sustained attention - maximum total time on the DVT
Sustained attention - maximum total time on the DVT
Time frame: Day 1
Sustained attention - maximum total time on the DVT
Sustained attention - maximum total time on the DVT
Time frame: Day 8
Sustained attention - maximum total time on the DVT
Sustained attention - maximum total time on the DVT
Time frame: Day 15
Sustained attention - maximum total time on the DVT
Sustained attention - maximum total time on the DVT
Time frame: Day 22
Sustained attention - maximum total time on the DVT
Sustained attention - maximum total time on the DVT
Time frame: Day 29
Sustained attention - maximum total time on the DVT
Sustained attention - maximum total time on the DVT
Time frame: Day 36
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
Time frame: Day 1
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
Time frame: Day 8
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
Time frame: Day 15
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
Time frame: Day 22
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
Time frame: Day 29
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
Time frame: Day 36
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
Time frame: Day 1
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
Time frame: Day 8
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
Time frame: Day 15
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
Time frame: Day 22
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
Time frame: Day 29
Pharmacokinetic profile of THCv
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
Time frame: Day 36