Trial Outcomes & Findings for Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions (NCT NCT06192589)
NCT ID: NCT06192589
Last Updated: 2025-07-31
Results Overview
The upper limit of normal (ULN), based on consensus criteria, for the liver transaminase ALT (Alanine transaminase) is defined as 33 U/L for males and 25 U/L for females. An ALT evaluation three times the ULN for males would be 99 U/L and 75 U/L for females.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
241 participants
Primary outcome timeframe
Days 1 through 35
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
Cannabidiol (Part 1)
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Cannabidiol and Citalopram Drug Interaction (Part 2)
Subjects in this arm will receive citalopram (20 mg) on Day 1 and Day 13 and oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 12 days (Day 6-17).
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
Citalopram: Citalopram (Celexa) will be administered once at 20 mg on days 1 and 13.
|
Cannabidiol and Morphine Drug Interaction (Part 2)
Subjects in this arm will receive morphine (15 mg) on Day 1, Day 4, and Day 11 and oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg CBD daily) for 9 days (Day 4-12).
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
Morphine: Morphine will be administered once at 15 mg on days 1, 4, and 11.
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|---|---|---|---|---|
|
Overall Study
STARTED
|
151
|
50
|
20
|
20
|
|
Overall Study
COMPLETED
|
133
|
47
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
18
|
3
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions
Baseline characteristics by cohort
| Measure |
Cannabidiol (Part 1)
n=151 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=50 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Citalopram and Cannabidiol (Part 2)
n=20 Participants
Subjects in this arm will receive citalopram (20 mg) on Day 1 and Day 13 and oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 12 days (Day 6-17).
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
Citalopram: Citalopram (Celexa) will be administered once at 20 mg on days 1 and 13.
|
Morphine and Cannabidiol (Part 2)
n=20 Participants
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
Morphine: Morphine sulfate tablet will be administered once at 15 mg on days 1, 4 and 11.
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Total
n=241 Participants
Total of all reporting groups
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|---|---|---|---|---|---|
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Age, Continuous
|
36 years
n=99 Participants
|
32 years
n=107 Participants
|
37 years
n=206 Participants
|
38 years
n=7 Participants
|
36 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
104 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
137 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
104 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
117 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Median Body Weight
|
80.2 kg
n=99 Participants
|
75.9 kg
n=107 Participants
|
79.5 kg
n=206 Participants
|
82.7 kg
n=7 Participants
|
80.1 kg
n=31 Participants
|
|
Median Height
|
1.71 m
n=99 Participants
|
1.72 m
n=107 Participants
|
1.74 m
n=206 Participants
|
1.76 m
n=7 Participants
|
1.72 m
n=31 Participants
|
|
Median Body Mass Index
|
27.1 kg/m2
n=99 Participants
|
26 kg/m2
n=107 Participants
|
26.6 kg/m2
n=206 Participants
|
26.7 kg/m2
n=7 Participants
|
26.7 kg/m2
n=31 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 35Population: The liver safety analysis population will include all subjects who receive at least 1 dose of the study drug and have at least one on-treatment liver and hematology lab assessment. Subjects in the liver safety analysis population will be used for the planned primary, secondary, and exploratory analyses related to liver enzyme elevations and liver events. Results will be reported as percentages with a 95% confidence interval (CI) based on a Kaplan-Meier analysis.
The upper limit of normal (ULN), based on consensus criteria, for the liver transaminase ALT (Alanine transaminase) is defined as 33 U/L for males and 25 U/L for females. An ALT evaluation three times the ULN for males would be 99 U/L and 75 U/L for females.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=151 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=50 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
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Part 1 - Percentage of Participants With an Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Liver Enzyme Elevation Greater Than Three Times the Upper Limit of Normal (> 3 × ULN).
|
5.6 percentage of participants
Interval 1.8 to 9.3
|
0 percentage of participants
Interval 0.0 to 7.6
|
—
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after each citalopram dose (Days 1 and 13)Population: All subjects who receive at least one dose of study drug and have at least one on-treatment PK sample collected. One subject was removed from the analysis due to a protocol violation.
AUC will be determined by collecting pharmacokinetic (PK) blood samples and calculated using noncompartmental analysis. 13 PK samples will be obtained with each citalopram dose for a total number of 26 PK samples per citalopram cohort participant. The outcome measure reported will be the geometric mean ratio for citalopram alone compared to citalopram after 7 days of CBD dosing.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=19 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=19 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
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|---|---|---|---|
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Part 2 - Area Under the Plasma Concentration-time Curve (AUC) of Citalopram When Administered Alone Versus When Co-administered With Cannabidiol After 7 Days of CBD Dosing.
|
1033 ng*hr/mL
Geometric Coefficient of Variation 26
|
1475 ng*hr/mL
Geometric Coefficient of Variation 24
|
—
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after each citalopram dose (Days 1 and 13)Population: All subjects who receive at least one dose of study drug and have at least one on-treatment PK sample collected. One subject was removed from the analysis due to a protocol violation.
Cmax will be determined by collecting pharmacokinetic (PK) blood samples and calculated using noncompartmental analysis. 13 PK samples will be obtained with each citalopram dose for a total number of 26 PK samples per citalopram cohort participant. The outcome measure reported will be the geometric mean ratio for citalopram alone compared to citalopram after 7 days of CBD dosing.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=19 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=19 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
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|---|---|---|---|
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Part 2 - Maximum Concentration (Cmax) of Citalopram When Administered Alone Versus When Co-administered With CBD After 7 Days of Cannabidiol Dosing.
|
23 ng/mL
Geometric Coefficient of Variation 21
|
26 ng/mL
Geometric Coefficient of Variation 24
|
—
|
PRIMARY outcome
Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after each morphine dose (Days 1, 4, and 11)Population: All subjects who receive at least one dose of study drug and have at least one on-treatment PK sample collected. For morphine and its metabolites, number of subjects is 20 for morphine alone and morphine with a single dose of CBD. For morphine with multiple doses of CBD, the sample size is 18 as two subjects discontinued from the study.
AUC will be determined by collecting pharmacokinetic (PK) blood samples and calculated using noncompartmental analysis.13 PK samples will be obtained with each morphine dose for a total number of 39 PK samples per morphine cohort participant. The outcome measure reported will be the geometric mean ratio for morphine alone compared to morphine after 7 days of CBD dosing.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
n=18 Participants
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
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|---|---|---|---|
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Part 2 - Morphine AUC When Administered Alone Versus When Co-administered With the First Dose of Cannabidiol and After 7 Days of CBD Dosing.
|
44 ng*hr/mL
Geometric Coefficient of Variation 45
|
47 ng*hr/mL
Geometric Coefficient of Variation 51
|
51 ng*hr/mL
Geometric Coefficient of Variation 60
|
PRIMARY outcome
Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after each morphine dose (Days 1, 4, and 11)Population: All subjects who receive at least one dose of study drug and have at least one on-treatment PK sample collected. For morphine and its metabolites, number of subjects is 20 for morphine alone and morphine with a single dose of CBD. For morphine with multiple doses of CBD, the sample size is 18 as two subjects discontinued from the study.
Cmax will be determined by collecting pharmacokinetic (PK) blood samples and calculated using noncompartmental analysis.13 PK samples will be obtained with each morphine dose for a total number of 39 PK samples per morphine cohort participant. The outcome measure reported will be the geometric mean ratio for morphine alone compared to morphine after 7 days of CBD dosing.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
n=18 Participants
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 2 - Morphine Cmax When Administered Alone Versus When Co-administered With the First Dose of Cannabidiol and After 7 Days of Cannabidiol Dosing.
|
8.3 ng/mL
Geometric Coefficient of Variation 40
|
9.9 ng/mL
Geometric Coefficient of Variation 45
|
9.3 ng/mL
Geometric Coefficient of Variation 31
|
SECONDARY outcome
Timeframe: Days 1 through 35Population: The liver safety analysis population will include all subjects who receive at least 1 dose of the study drug and have at least one on-treatment liver and hematology lab assessment. Subjects in the liver safety analysis population will be used for the planned primary, secondary, and exploratory analyses related to liver enzyme elevations and liver events. Results will be reported as percentages with a 95% confidence interval (CI) based on a Kaplan-Meier analysis.
Withdrawal criteria for potential drug-induced liver-injury: laboratory results meeting any of the following criteria. * ALT or AST \> 3 x ULN (ULN for ALT is 33 U/L for males and 25 U/L for females) with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (\> 5%) OR * ALT elevation ≥ 5 × ULN (ULN for ALT is 33 U/L for males and 25 U/L for females) OR * Alkaline phosphatase (ALP) elevation ≥ 2 × ULN (with accompanying elevations of gamma-glutamyl transpeptidase (GGT) in the absence of known bone pathology driving the rise in ALP level) OR * ALT elevation ≥ 3 × ULN and bilirubin concentration \> 2 × ULN
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=151 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=50 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 1 - Percentage of Participants Meeting Withdrawal Criteria for Potential Drug-induced Liver Injury (DILI).
|
4.9 percentage of participants
Interval 1.3 to 8.4
|
0 percentage of participants
Interval 0.0 to 7.6
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: Analyses include male participants with time-matched samples at day 1 and 29
Endocrine assessments for total testosterone will be obtained through blood samples. A linear mixed effect model will be utilized to obtain least squares means for each treatment group.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=77 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=26 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 1 - Change From Baseline in Total Testosterone in Male Participants After Cannabidiol Administration Compared to Placebo.
|
5.0 ng/dL
Interval -20.0 to 30.0
|
-13.6 ng/dL
Interval -57.1 to 29.9
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: Analyses include male participants with time-matched samples at day 1 and 29
Endocrine assessments for inhibin B will be obtained through blood samples. A linear mixed effect model will be utilized to obtain least squares means for each treatment group.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=77 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=26 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 1 - Change From Baseline in Inhibin B in Male Participants After Cannabidiol Administration Compared to Placebo.
|
5.8 pg/mL
Interval 0.8 to 10.7
|
8.2 pg/mL
Interval 0.0 to 16.5
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: Analyses include all participants with time-matched samples at day 1 and 29. Participants without day 29 samples (e.g., discontinued treatment prior to day 29) were excluded from the analysis.
Endocrine assessments for TSH will be obtained through blood samples. A linear mixed effect model will be utilized to obtain least squares means for each treatment group.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=139 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=47 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 1 - Change From Baseline in Thyroid Stimulating Hormone (TSH) After Cannabidiol Administration Compared to Placebo.
|
0.073 mU/mL
Interval -0.003 to 0.148
|
0.005 mU/mL
Interval -0.124 to 0.134
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: Analyses include all participants with time-matched samples at day 1 and 29. Participants without day 29 samples (e.g., discontinued treatment prior to day 29) were excluded from the analysis.
Endocrine assessments for total T3 will be obtained through blood samples. A linear mixed effect model will be utilized to obtain least squares means for each treatment group.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=139 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=47 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 1 - Change From Baseline in Total T3 After Cannabidiol Administration Compared to Placebo.
|
-0.006 ng/mL
Interval -0.023 to 0.011
|
0.014 ng/mL
Interval -0.015 to 0.043
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: Analyses include all participants with time-matched samples at day 1 and 29. Participants without day 29 samples (e.g., discontinued treatment prior to day 29) were excluded from the analysis.
Endocrine assessments for free T4 will be obtained through blood samples. A linear mixed effect model will be utilized to obtain least squares means for each treatment group.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=139 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=47 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 1 - Change From Baseline in Free T4 After Cannabidiol Administration Compared to Placebo.
|
-0.014 ng/mL
Interval -0.025 to -0.003
|
-0.012 ng/mL
Interval -0.031 to 0.006
|
—
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after each morphine dose (Days 1, 4, and 11)Population: All subjects who receive at least one dose of study drug and have at least one on-treatment PK sample collected. For morphine and its metabolites, number of subjects is 20 for morphine alone and morphine with a single dose of CBD. For morphine with multiple doses of CBD, the sample size is 18 as two subjects discontinued from the study.
AUC will be determined by collecting pharmacokinetic (PK) blood samples and calculated using noncompartmental analysis.13 PK samples will be obtained with each morphine dose for a total number of 39 PK samples per morphine cohort participant. The outcome measure reported will be the geometric mean ratio for morphine-3-glucuronide (M3G) alone compared to morphine-3-glucuronide (M3G) after 7 days of CBD dosing.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
n=18 Participants
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 2 - Morphine-3-glucuronide (M3G) AUC When Morphine is Administered Alone Versus When Co-administered With Cannabidiol.
|
2416 ng*hr/mL
Geometric Coefficient of Variation 18
|
2450 ng*hr/mL
Geometric Coefficient of Variation 17
|
2382 ng*hr/mL
Geometric Coefficient of Variation 14
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after each morphine dose (Days 1, 4, and 11)Population: All subjects who receive at least one dose of study drug and have at least one on-treatment PK sample collected. For morphine and its metabolites, number of subjects is 20 for morphine alone and morphine with a single dose of CBD. For morphine with multiple doses of CBD, the sample size is 18 as two subjects discontinued from the study.
Cmax will be determined by collecting pharmacokinetic (PK) blood samples and calculated using noncompartmental analysis.13 PK samples will be obtained with each morphine dose for a total number of 39 PK samples per morphine cohort participant. The outcome measure reported will be the geometric mean ratio for morphine-3-glucuronide (M3G) alone compared to morphine-3-glucuronide (M3G) after 7 days of CBD dosing.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
n=18 Participants
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 2 - M3G Cmax When Morphine is Administered Alone Versus When Co-administered With Cannabidiol.
|
265 ng/mL
Geometric Coefficient of Variation 21
|
296 ng/mL
Geometric Coefficient of Variation 29
|
256 ng/mL
Geometric Coefficient of Variation 25
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after each morphine dose (Days 1, 4, and 11)Population: All subjects who receive at least one dose of study drug and have at least one on-treatment PK sample collected. For morphine and its metabolites, number of subjects is 20 for morphine alone and morphine with a single dose of CBD. For morphine with multiple doses of CBD, the sample size is 18 as two subjects discontinued from the study.
AUC will be determined by collecting pharmacokinetic (PK) blood samples and calculated using noncompartmental analysis.13 PK samples will be obtained with each morphine dose for a total number of 39 PK samples per morphine cohort participant. The outcome measure reported will be the geometric mean ratio for morphine-6-glucuronide (M6G) alone compared to morphine-6-glucuronide (M6G) after 7 days of CBD dosing.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
n=18 Participants
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 2 - Morphine-6-glucuronide (M6G) AUC When Morphine is Administered Alone Versus When Co-administered With Cannabidiol.
|
327 ng*hr/mL
Geometric Coefficient of Variation 30
|
355 ng*hr/mL
Geometric Coefficient of Variation 28
|
416 ng*hr/mL
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after each morphine dose (Days 1, 4, and 11)Population: All subjects who receive at least one dose of study drug and have at least one on-treatment PK sample collected. For morphine and its metabolites, number of subjects is 20 for morphine alone and morphine with a single dose of CBD. For morphine with multiple doses of CBD, the sample size is 18 as two subjects discontinued from the study.
Cmax will be determined by collecting pharmacokinetic (PK) blood samples and calculated using noncompartmental analysis.13 PK samples will be obtained with each morphine dose for a total number of 39 PK samples per morphine cohort participant. The outcome measure reported will be the geometric mean ratio for morphine-6-glucuronide (M6G) alone compared to morphine-6-glucuronide (M6G) after 7 days of CBD dosing.
Outcome measures
| Measure |
Cannabidiol (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=20 Participants
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Part 2: Morphine and Multiple Doses of Cannabidiol
n=18 Participants
Subjects in this arm will receive morphine (15 mg) on Day 1 (baseline), Day 4, and Day 11 (with CBD). Oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 9 days (Day 4-12).
Reported data is for morphine exposures from morphine following multiple doses of cannabidiol (Day 11-12).
|
|---|---|---|---|
|
Part 2 - M6G Cmax When Morphine is Administered Alone Versus When Co-administered With Cannabidiol.
|
47 ng/mL
Geometric Coefficient of Variation 24
|
51 ng/mL
Geometric Coefficient of Variation 28
|
52 ng/mL
Geometric Coefficient of Variation 28
|
Adverse Events
Cannabidiol (Part 1)
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo (Part 1)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cannabidiol and Citalopram Drug Interaction (Part 2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cannabidiol and Morphine Drug Interaction (Part 2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cannabidiol (Part 1)
n=151 participants at risk
Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
|
Placebo (Part 1)
n=50 participants at risk
Subjects in this arm will receive oral solution placebo twice a day for 28 days.
Placebo: Placebo will be administered orally twice daily for 28 days in Part 1
|
Cannabidiol and Citalopram Drug Interaction (Part 2)
n=20 participants at risk
Subjects in this arm will receive citalopram (20 mg) on Day 1 and Day 13 and oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 12 days (Day 6-17).
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
Citalopram: Citalopram (Celexa) will be administered once at 20 mg on days 1 and 13.
|
Cannabidiol and Morphine Drug Interaction (Part 2)
n=20 participants at risk
Subjects in this arm will receive morphine (15 mg) on Day 1, Day 4, and Day 11 and oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg CBD daily) for 9 days (Day 4-12).
Cannabidiol: Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.
Morphine: Morphine will be administered once at 15 mg on days 1, 4, and 11.
|
|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
1.3%
2/151 • Number of events 2 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Skin and subcutaneous tissue disorders
Application Site Irritation
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Skin and subcutaneous tissue disorders
Arthropod Bite
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
General disorders
Back Pain
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
2.0%
1/50 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
|
Infections and infestations
Bacterial Vaginosis
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Gastrointestinal disorders
Constipation
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
6/151 • Number of events 6 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
10.0%
2/20 • Number of events 3 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
|
Nervous system disorders
Dizziness
|
2.6%
4/151 • Number of events 4 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
|
General disorders
Dry Mouth
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Blood and lymphatic system disorders
Eosinophilia
|
4.6%
7/151 • Number of events 7 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Vascular disorders
Epistaxis
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
General disorders
Fatigue
|
1.3%
2/151 • Number of events 2 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Gastrointestinal disorders
Flatulence
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
General disorders
Headache
|
2.6%
4/151 • Number of events 4 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
10.0%
2/20 • Number of events 3 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Hepatobiliary disorders
Hepatic Enzyme Increase
|
5.3%
8/151 • Number of events 8 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Psychiatric disorders
Insomnia
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
4.0%
2/50 • Number of events 3 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy Cervical
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
2.0%
1/50 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
General disorders
Nasal Congestion
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
2.0%
1/50 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Psychiatric disorders
Nightmares
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Infections and infestations
Pharyngitis
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
General disorders
Somnolence
|
3.3%
5/151 • Number of events 6 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
2.0%
1/50 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
General disorders
Toothache
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.6%
4/151 • Number of events 4 • Part 1: 36 days Part 2: 24 days
|
4.0%
2/50 • Number of events 2 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
|
Renal and urinary disorders
Urine Odor Foul
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Infections and infestations
Urogenital Trichomoniasis
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Vascular disorders
Venipuncture Site Hematoma
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
2.0%
1/50 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Infections and infestations
Viral Syndrome
|
2.0%
3/151 • Number of events 4 • Part 1: 36 days Part 2: 24 days
|
2.0%
1/50 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/151 • Number of events 2 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Gastrointestinal disorders
Bloating
|
1.3%
2/151 • Number of events 2 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Gastrointestinal disorders
Distention
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
General disorders
Feeling Hot
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Nervous system disorders
Presyncope
|
1.3%
2/151 • Number of events 2 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Skin and subcutaneous tissue disorders
Skin Abrasion
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Skin and subcutaneous tissue disorders
Thermal Burn
|
0.66%
1/151 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 2 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
|
Investigations
COVID-19 serology test positive
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
|
General disorders
Decreased Appetite
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
15.0%
3/20 • Number of events 4 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
|
Cardiac disorders
Non-sustained ventricular tachycardia
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/151 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/50 • Part 1: 36 days Part 2: 24 days
|
5.0%
1/20 • Number of events 1 • Part 1: 36 days Part 2: 24 days
|
0.00%
0/20 • Part 1: 36 days Part 2: 24 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place