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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Placebo | Placebo Comparator | Single oral administration of 4 ml of Placebo MCT oil |
|
| Group 2: 12.5 mg THCv (CHI-915) | Active Comparator | Single oral administration of 12.5 mg THCv in MCT oil |
|
| Group 3: 25 mg THCv (CHI-915) | Active Comparator | Single oral administration of 25 mg THCv in MCT oil |
|
| Group 4: 50 mg THCv (CHI-915) | Active Comparator | Single oral administration of 50 mg THCv in MCT oil |
|
| Group 5: 100 mg THCv (CHI-915) | Active Comparator | Single oral administration of 100 mg THCv in MCT oil |
|
| Group 6: 200 mg THCv (CHI-915) | Active Comparator | Single oral administration of 200 mg THCv in MCT oil |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THCv | Dietary Supplement | THCv in MCT oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, type and severity of AEs/SAEs | Incidence, type and severity of AEs/SAEs | Day 1 |
| Incidence, type and severity of AEs/SAEs | Incidence, type and severity of AEs/SAEs | Day 8 |
| Incidence, type and severity of AEs/SAEs | Incidence, type and severity of AEs/SAEs | Day 15 |
| Incidence, type and severity of AEs/SAEs | Incidence, type and severity of AEs/SAEs | Day 22 |
| Incidence, type and severity of AEs/SAEs | Incidence, type and severity of AEs/SAEs | Day 29 |
| Incidence, type and severity of AEs/SAEs | Incidence, type and severity of AEs/SAEs | Day 36 |
| Change in blood pressure | Change in systolic and diastolic blood pressure measured in mmHg | Day 1 |
| Change in heart rate | Change in heart rate measured in beats per minute | Day 1 |
| Change in respiratory rate |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | Day 1 |
| Maximum effect for the item "energetic" on the DEQ |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Saint Paul | Minnesota | 55114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42250012 | Derived | Sempio C, Campos-Palomino J, Klawitter J, Peters EN, MacNair L, Haghdoost M, Bonn-Miller M, Harrison A, Babalonis S, Huestis MA, Christians U, Klawitter J. Metabolite patterns in human urine after oral administration of highly purified Delta8-THCV. Forensic Toxicol. 2026 Jul;44(2):437-444. doi: 10.1007/s11419-026-00772-5. Epub 2026 Jun 6. | |
| 39770444 |
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The is a two-phase, within participant crossover study.
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Phase 1 will follow a single-ascending dose design in 3 participants. This portion of the study will be unblinded. Phase 2 will follow a within-participant crossover design in 15 participants. Participants will be randomized to a dosing order. Phase 2 is double-blind.
|
Change in respiratory rate measured in breaths per minute |
| Day 1 |
| Change in body temperature | Change in body temperature measured in degrees Celsius | Day 1 |
| Change in blood pressure | Change in systolic and diastolic blood pressure measured in mmHg | Day 8 |
| Change in heart rate | Change in heart rate measured in beats per minute | Day 8 |
| Change in respiratory rate | Change in respiratory rate measured in breaths per minute | Day 8 |
| Change in body temperature | Change in body temperature measured in degrees Celsius | Day 8 |
| Change in blood pressure | Change in systolic and diastolic blood pressure measured in mmHg | Day 15 |
| Change in respiratory rate | Change in respiratory rate measured in breaths per minute | Day 15 |
| Change in heart rate | Change in heart rate measured in beats per minute | Day 15 |
| Change in body temperature | Change in body temperature measured in degrees Celsius | Day 15 |
| Change in blood pressure | Change in systolic and diastolic blood pressure measured in mmHg | Day 22 |
| Change in respiratory rate | Change in respiratory rate measured in breaths per minute | Day 22 |
| Change in heart rate | Change in heart rate measured in beats per minute | Day 22 |
| Change in body temperature | Change in body temperature measured in degrees Celsius | Day 22 |
| Change in blood pressure | Change in systolic and diastolic blood pressure measured in mmHg | Day 29 |
| Change in heart rate | Change in heart rate measured in beats per minute | Day 29 |
| Change in respiratory rate | Change in respiratory rate measured in breaths per minute | Day 29 |
| Change in body temperature | Change in body temperature measured in degrees Celsius | Day 29 |
| Change in blood pressure | Change in systolic and diastolic blood pressure measured in mmHg | Day 36 |
| Change in heart rate | Change in heart rate measured in beats per minute | Day 36 |
| Change in respiratory rate | Change in respiratory rate measured in breaths per minute | Day 36 |
| Change in body temperature | Change in body temperature measured in degrees Celsius | Day 36 |
| Change in ECG results | Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant | Day 1 |
| Change in ECG results | Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant | Day 8 |
| Change in ECG results | Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant | Day 15 |
| Change in ECG results | Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant | Day 22 |
| Change in ECG results | Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant | Day 29 |
| Change in ECG results | Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant | Day 36 |
Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"
| 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" | 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" | 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" | 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" | Day 36 |
| Sustained attention - maximum total time on the DVT | Sustained attention - maximum total time on the DVT | Day 1 |
| Sustained attention - maximum total time on the DVT | Sustained attention - maximum total time on the DVT | Day 8 |
| Sustained attention - maximum total time on the DVT | Sustained attention - maximum total time on the DVT | Day 15 |
| Sustained attention - maximum total time on the DVT | Sustained attention - maximum total time on the DVT | Day 22 |
| Sustained attention - maximum total time on the DVT | Sustained attention - maximum total time on the DVT | Day 29 |
| Sustained attention - maximum total time on the DVT | Sustained attention - maximum total time on the DVT | Day 36 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by maximum observed plasma concentration | Day 1 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by maximum observed plasma concentration | Day 8 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by maximum observed plasma concentration | Day 15 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by maximum observed plasma concentration | Day 22 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by maximum observed plasma concentration | Day 29 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by maximum observed plasma concentration | Day 36 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration | Day 1 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration | Day 8 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration | Day 15 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration | Day 22 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration | Day 29 |
| Pharmacokinetic profile of THCv | Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration | Day 36 |
| Sempio C, Campos-Palomino J, Klawitter J, Peters EN, MacNair L, Haghdoost M, Bonn-Miller MO, Harrison A, Babalonis S, Christians U, Klawitter J. Pharmacokinetics of Oral Cannabinoid Delta8-Tetrahydrocannabivarin and Its Main Metabolites in Healthy Participants. Pharmaceuticals (Basel). 2024 Nov 27;17(12):1603. doi: 10.3390/ph17121603. |
| 37721990 | Derived | Peters EN, MacNair L, Harrison A, Feldner MT, Eglit GML, Babalonis S, Turcotte C, Bonn-Miller MO. A Two-Phase, Dose-Ranging, Placebo-Controlled Study of the Safety and Preliminary Test of Acute Effects of Oral Delta8-Tetrahydrocannabivarin in Healthy Participants. Cannabis Cannabinoid Res. 2023 Sep;8(S1):S71-S82. doi: 10.1089/can.2023.0038. |