- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05210634
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CHI-915 in Healthy Participants
11 maj 2022 uppdaterad av: Canopy Growth Corporation
A Two-Phase, Randomized, Double-Blind, PlaceboControlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CHI-915 in Healthy Participants
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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
21
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Minnesota
-
Saint Paul, Minnesota, Förenta staterna, 55114
- Nucleus Network
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Is a healthy adult aged 18-55 years (inclusive) at the time of screening.
- Has a body mass index between 18 and 30 kg/m2.
- Is judged by the Investigator to be in generally good health at screening based on the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. Laboratory results outside of the reference range deemed to be acceptable will be documented as not clinically significant at the discretion of the Investigator.
- For women of childbearing potential, has a negative serum pregnancy test (β-human chorionic gonadotropin [hCG]) at the Screening Visit and a negative urine pregnancy test at intake to the research facility.
- Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
- Is, in the Investigator's opinion, reliable, able, and willing to comply with all protocol requirements and procedures (including scheduled visits).
Exclusion Criteria:
- Women who are pregnant, lactating, breastfeeding, or planning a pregnancy.
- Women of childbearing potential, or men who are sexually active with a woman of childbearing potential, who are unwilling or unable to use an acceptable method of contraception (abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, or intrauterine device) from at least 21 days prior to the first dose of study medication until 28 days after the last dose of study medication. Participants with same sex partners or who maintain abstinence do not require contraception.
- Person has history of diagnosis related to hepatic function and/or significantly impaired hepatic function (alanine aminotransferase [ALT] >3x upper limit of normal [ULN] or total bilirubin [TBL] >2 x ULN) OR the ALT or aspartate aminotransferase (AST) >2 x ULN and TBL >2 x ULN (or international normalized ratio [INR] >1.5).
- Has a history of epilepsy.
- Has used tobacco/nicotine-containing products on more than 10 occasions within 30 days of dosing with study IP or during the study.
- Has used any prescription drugs or herbal supplements (except hormonal contraception) within 30 days prior to receiving the first dose of IP, unless approved by the Investigator and stable for at least 30 days prior to the first dose of IP through the final study visit.
- Use of any over-the-counter drugs, vitamins, or supplements within 24 hours prior to dosing with the IP.
- Has or has previously had a positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCVAb), or human immunodeficiency virus (HIV) antibodies.
- Has a positive breath, urine, or serum test for ethanol or a positive urine screen for cocaine, THC, barbiturates, amphetamines, methamphetamines, benzodiazepines, methylenedioxymethamphetamine, phencyclidine, methadone, or opiates at the Screening Visit or prior to IP administration.
- Any clinically significant condition or abnormal finding at the Screening Visit that would, in the opinion of the Investigator, preclude study participation or interfere with evaluation of the IP.
- Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP.
- Has taken grapefruit products and/or Seville oranges within the 7 days prior to dosing with study medication or during the study.
- Is taking a prohibited medication or supplement including warfarin, clobazam, valproic acid, phenobarbital, mTOR inhibitors, oral tacrolimus, and St. John's Wort within 30 days prior to receiving the first dose of IP or during the study.
- Has used cannabis, synthetic cannabinoid, or cannabinoid analogues (e.g., dronabinol, nabilone), hemp products, synthetic cannabinoid receptor agonists (e.g., spice, K2), or any cannabidiol (CBD) or THC-containing product (e.g., Sativex, Epidiolex) within 4 weeks of the Screening Visit or during the study and has used cannabis on more than 25 occasions in the last 12 months.
- Meets criteria for past-year Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)-defined psychiatric disorder, or moderate to severe substance use disorder.
- Has a lifetime history of psychosis or schizophrenia or a first-degree relative experiencing psychosis or schizophrenia.
- Endorses current suicidal intent as indexed by endorsement of questions #4 or #5 on the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Has suspected or confirmed cardiovascular disease.
- Has participated in any investigational product or device study within 30 days prior to receiving the first dose of IP or is scheduled to participate in another investigational product or device study during the course of this study.
- Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Group 1: Placebo
Single oral administration of 4 ml of Placebo MCT oil
|
THCv in MCT oil
|
Aktiv komparator: Group 2: 12.5 mg THCv (CHI-915)
Single oral administration of 12.5 mg THCv in MCT oil
|
THCv in MCT oil
|
Aktiv komparator: Group 3: 25 mg THCv (CHI-915)
Single oral administration of 25 mg THCv in MCT oil
|
THCv in MCT oil
|
Aktiv komparator: Group 4: 50 mg THCv (CHI-915)
Single oral administration of 50 mg THCv in MCT oil
|
THCv in MCT oil
|
Aktiv komparator: Group 5: 100 mg THCv (CHI-915)
Single oral administration of 100 mg THCv in MCT oil
|
THCv in MCT oil
|
Aktiv komparator: Group 6: 200 mg THCv (CHI-915)
Single oral administration of 200 mg THCv in MCT oil
|
THCv in MCT oil
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Incidence, type and severity of AEs/SAEs
Tidsram: Day 1
|
Incidence, type and severity of AEs/SAEs
|
Day 1
|
Incidence, type and severity of AEs/SAEs
Tidsram: Day 8
|
Incidence, type and severity of AEs/SAEs
|
Day 8
|
Incidence, type and severity of AEs/SAEs
Tidsram: Day 15
|
Incidence, type and severity of AEs/SAEs
|
Day 15
|
Incidence, type and severity of AEs/SAEs
Tidsram: Day 22
|
Incidence, type and severity of AEs/SAEs
|
Day 22
|
Incidence, type and severity of AEs/SAEs
Tidsram: Day 29
|
Incidence, type and severity of AEs/SAEs
|
Day 29
|
Incidence, type and severity of AEs/SAEs
Tidsram: Day 36
|
Incidence, type and severity of AEs/SAEs
|
Day 36
|
Change in blood pressure
Tidsram: Day 1
|
Change in systolic and diastolic blood pressure measured in mmHg
|
Day 1
|
Change in heart rate
Tidsram: Day 1
|
Change in heart rate measured in beats per minute
|
Day 1
|
Change in respiratory rate
Tidsram: Day 1
|
Change in respiratory rate measured in breaths per minute
|
Day 1
|
Change in body temperature
Tidsram: Day 1
|
Change in body temperature measured in degrees Celsius
|
Day 1
|
Change in blood pressure
Tidsram: Day 8
|
Change in systolic and diastolic blood pressure measured in mmHg
|
Day 8
|
Change in heart rate
Tidsram: Day 8
|
Change in heart rate measured in beats per minute
|
Day 8
|
Change in respiratory rate
Tidsram: Day 8
|
Change in respiratory rate measured in breaths per minute
|
Day 8
|
Change in body temperature
Tidsram: Day 8
|
Change in body temperature measured in degrees Celsius
|
Day 8
|
Change in blood pressure
Tidsram: Day 15
|
Change in systolic and diastolic blood pressure measured in mmHg
|
Day 15
|
Change in respiratory rate
Tidsram: Day 15
|
Change in respiratory rate measured in breaths per minute
|
Day 15
|
Change in heart rate
Tidsram: Day 15
|
Change in heart rate measured in beats per minute
|
Day 15
|
Change in body temperature
Tidsram: Day 15
|
Change in body temperature measured in degrees Celsius
|
Day 15
|
Change in blood pressure
Tidsram: Day 22
|
Change in systolic and diastolic blood pressure measured in mmHg
|
Day 22
|
Change in respiratory rate
Tidsram: Day 22
|
Change in respiratory rate measured in breaths per minute
|
Day 22
|
Change in heart rate
Tidsram: Day 22
|
Change in heart rate measured in beats per minute
|
Day 22
|
Change in body temperature
Tidsram: Day 22
|
Change in body temperature measured in degrees Celsius
|
Day 22
|
Change in blood pressure
Tidsram: Day 29
|
Change in systolic and diastolic blood pressure measured in mmHg
|
Day 29
|
Change in heart rate
Tidsram: Day 29
|
Change in heart rate measured in beats per minute
|
Day 29
|
Change in respiratory rate
Tidsram: Day 29
|
Change in respiratory rate measured in breaths per minute
|
Day 29
|
Change in body temperature
Tidsram: Day 29
|
Change in body temperature measured in degrees Celsius
|
Day 29
|
Change in blood pressure
Tidsram: Day 36
|
Change in systolic and diastolic blood pressure measured in mmHg
|
Day 36
|
Change in heart rate
Tidsram: Day 36
|
Change in heart rate measured in beats per minute
|
Day 36
|
Change in respiratory rate
Tidsram: Day 36
|
Change in respiratory rate measured in breaths per minute
|
Day 36
|
Change in body temperature
Tidsram: Day 36
|
Change in body temperature measured in degrees Celsius
|
Day 36
|
Change in ECG results
Tidsram: Day 1
|
Change in ECG results.
Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
|
Day 1
|
Change in ECG results
Tidsram: Day 8
|
Change in ECG results.
Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
|
Day 8
|
Change in ECG results
Tidsram: Day 15
|
Change in ECG results.
Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
|
Day 15
|
Change in ECG results
Tidsram: Day 22
|
Change in ECG results.
Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
|
Day 22
|
Change in ECG results
Tidsram: Day 29
|
Change in ECG results.
Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
|
Day 29
|
Change in ECG results
Tidsram: Day 36
|
Change in ECG results.
Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant
|
Day 36
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Maximum effect for the item "energetic" on the DEQ
Tidsram: Day 1
|
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
Tidsram: Day 8
|
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
Tidsram: Day 15
|
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
Tidsram: Day 22
|
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
Tidsram: Day 29
|
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
Tidsram: Day 36
|
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
Tidsram: Day 1
|
Sustained attention - maximum total time on the DVT
|
Day 1
|
Sustained attention - maximum total time on the DVT
Tidsram: Day 8
|
Sustained attention - maximum total time on the DVT
|
Day 8
|
Sustained attention - maximum total time on the DVT
Tidsram: Day 15
|
Sustained attention - maximum total time on the DVT
|
Day 15
|
Sustained attention - maximum total time on the DVT
Tidsram: Day 22
|
Sustained attention - maximum total time on the DVT
|
Day 22
|
Sustained attention - maximum total time on the DVT
Tidsram: Day 29
|
Sustained attention - maximum total time on the DVT
|
Day 29
|
Sustained attention - maximum total time on the DVT
Tidsram: Day 36
|
Sustained attention - maximum total time on the DVT
|
Day 36
|
Pharmacokinetic profile of THCv
Tidsram: Day 1
|
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
|
Day 1
|
Pharmacokinetic profile of THCv
Tidsram: Day 8
|
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
|
Day 8
|
Pharmacokinetic profile of THCv
Tidsram: Day 15
|
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
|
Day 15
|
Pharmacokinetic profile of THCv
Tidsram: Day 22
|
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
|
Day 22
|
Pharmacokinetic profile of THCv
Tidsram: Day 29
|
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
|
Day 29
|
Pharmacokinetic profile of THCv
Tidsram: Day 36
|
Pharmacokinetic profile of THCv measured by maximum observed plasma concentration
|
Day 36
|
Pharmacokinetic profile of THCv
Tidsram: Day 1
|
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
|
Day 1
|
Pharmacokinetic profile of THCv
Tidsram: Day 8
|
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
|
Day 8
|
Pharmacokinetic profile of THCv
Tidsram: Day 15
|
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
|
Day 15
|
Pharmacokinetic profile of THCv
Tidsram: Day 22
|
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
|
Day 22
|
Pharmacokinetic profile of THCv
Tidsram: Day 29
|
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
|
Day 29
|
Pharmacokinetic profile of THCv
Tidsram: Day 36
|
Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration
|
Day 36
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 januari 2022
Primärt slutförande (Faktisk)
6 maj 2022
Avslutad studie (Faktisk)
6 maj 2022
Studieregistreringsdatum
Först inskickad
31 december 2021
Först inskickad som uppfyllde QC-kriterierna
14 januari 2022
Första postat (Faktisk)
27 januari 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 maj 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 maj 2022
Senast verifierad
1 maj 2022
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 710022US1312
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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