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| ID | Type | Description | Link |
|---|---|---|---|
| 75F40121C00199 | Other Identifier | DHHS / FDA / OAGS / DAO |
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Kratom (Mitragyna speciosa) is a plant often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. Due to limited data availability, the goal of this clinical trial is to learn about safety, pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body) of Kratom in adult recreational polydrug users with opioid experience.
This is a phase I, single-dose, randomized, adaptive, double-blind, placebo-controlled, single ascending dose (SAD), sequential group study in adult recreational polydrug users with opioid experience performed at a single study center.
This study will consist of five cohorts.
Forty subjects are planned to participate. Eight subjects will participate in each cohort.
Within each cohort, 6 subjects will be randomized to receive Kratom and 2 subjects will be randomized to receive placebo. Each subject will be involved in the study for up to approximately 37 days (including screening).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, 1 g of Kratom | Experimental | A total of 6 subjects will receive an oral single dose administration of the active product |
|
| Cohort 2, 3 g of Kratom | Experimental | A total of 6 subjects will receive an oral single dose administration of the active product |
|
| Cohort 3, 8 g of Kratom | Experimental | A total of 6 subjects will receive an oral single dose administration of the active product |
|
| Cohort 4, 10 g of Kratom | Experimental | A total of 6 subjects will receive an oral single dose administration of the active product |
|
| Cohort 5, 12 g of Kratom | Experimental | A total of 6 subjects will receive an oral single dose administration of the active product |
|
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kratom | Drug | Single administration thirty minutes after the start of a high-fat breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 5.0). | Day 1 through Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration | Cmax (ng/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
| Time of Maximum Observed Concentration |
Not provided
Inclusion Criteria:
Provision of signed and dated informed consent form (ICF)
Stated willingness to comply with all study procedures and availability for the duration of the study
Healthy adult male or female
Current nondependent, polydrug recreational user who has used opioid drugs for recreational (nontherapeutic) purposes (i.e., for psychoactive effects) and has a history of recreational use of at least 2 or more of any of the perception-altering (e.g., lysergic acid diethylamide [LSD], kratom, cannabis, dronabinol, ketamine, phencyclidine [PCP], dextromethorphan, 3,4 methylenedioxymethamphetamine [MDMA], mescaline, psilocybin, tryptamine derivatives or ring-substituted amphetamines with perception altering effects) or stimulant (e.g., cocaine, amphetamine, methamphetamine, methylphenidate, methcathinone, and other synthetic cathinones) drugs
If male, meets one of the following criteria:
Is able to procreate and agrees to use one of the accepted contraceptive regimens and not to donate sperm from study drug administration to at least 90 days after study drug administration. An acceptable method of contraception includes one of the following:
Is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 180 days prior to study drug administration)
If female, meets one of the following criteria:
Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
a1. Abstinence from heterosexual intercourse from the Screening visit through to at least 30 days after study drug administration
a2. One of the following contraceptive methods, used from at least 28 days prior to the Screening visit through to at least 30 days after study drug administration:
a3. One of the following double-barrier contraceptive methods, used from the Screening visit through to at least 30 days study drug administration:
Is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation), or is in a postmenopausal state (i.e., at least 1 year without menses without an alternative medical condition prior to the Screening visit and follicle stimulating hormone levels ≥ 40 mIU/mL at Screening)
Body mass index (BMI) within 18.0 kg/m2 to 34.0 kg/m2, inclusively at Screening
Minimum weight of 50.0 kg at Screening
Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs, oxygen saturation [SpO2], and respiratory rate) and/or ECG, as determined by an Investigator
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Kansas, Inc. | Overland Park | Kansas | 66212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1, 1 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| FG001 | Cohort 2, 3 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| FG002 | Cohort 3, 8 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| FG003 | Cohort 4, 10 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| FG004 | Cohort 5, 12 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| FG005 | Placebo | A total of 2 subjects per cohort will receive an oral single dose administration of placebo Placebo: Single administration thirty minutes after the start of a high-fat breakfast |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1, 1 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| BG001 | Cohort 2, 3 g of Kratom |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 5.0). | Posted | Count of Participants | Participants | Day 1 through Day 7 |
|
37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1, 1 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraesthesia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment | Right arm paresthesia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Regulatory Affairs Associate | Altasciences | 450 973 3155 | 112084 | mgalarza@altasciences.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 5, 2023 | Aug 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 4, 2024 | Aug 14, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Pregnancy Partner Information Form | Jun 7, 2023 | Aug 14, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form | Jun 7, 2023 | Sep 9, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| C001801 | mitragynine |
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The treatment assignment (active or placebo) will not be known by the study participants. Study participants will be informed of the dose range they could receive but will not be informed of the actual dose assigned to them.
Furthermore, the randomization code will not be available to the Investigator and clinical staff involved in the collection, monitoring, revision, or evaluation of AEs, as well as clinical staff who could have an impact on the outcome of the study including the pharmacokineticist (or delegate) and biostatistician, until all the case report form (CRFs) have been approved and signed and the bioanalytical phase of the study has been completed.
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
|
| Placebo | Drug | Single administration thirty minutes after the start of a high-fat breakfast |
|
Tmax (hours) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine |
| 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
| Area Under the Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-T) | AUC0-T (ng*h/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
| Area Under the Concentration Time Curve Extrapolated to Infinity | AUC0-inf (ng*h/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
| Dose-normalized Cmax Calculated at Cmax / Dose | Cmax/D (ng/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
| Dose-normalized AUC0-T Calculated as AUC0-T / Dose | AUC0-T/D (ng*h/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
| Dose-normalized AUC0-inf Calculated as AUC0-inf / Dose | AUC0-inf/D (ng*h/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
| Maximum Effect for Drug Liking | Maximum (peak) effect (Emax) for Drug Liking assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "strong disliking" (score = 0), "neither like nor dislike" (score = 50) to "strong liking" (score = 100). | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose |
| Maximum Effect for Overall Drug Liking | Maximum (peak) effect (Emax) for Overall Drug Liking assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "strong disliking" (score = 0), "neither like nor dislike" (score = 50) to "strong liking" (score = 100). | 12 and 24 hours postdose |
| Maximum Effect for Take Drug Again | Maximum (peak) effect (Emax) for Take Drug Again assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "definitely would not" (score = 0), "neither would nor would not" (score = 50) to "definitely would" (score = 100). | 12 and 24 hours postdose |
| Maximum Effect for High | Maximum (peak) effect (Emax) for High assessed on an unipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "not at all" (score = 0) to "extremely" (score = 100). | Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose |
A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| BG002 | Cohort 3, 8 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| BG003 | Cohort 4, 10 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| BG004 | Cohort 5, 12 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| BG005 | Placebo | A total of 2 subjects per cohort will receive an oral single dose administration of placebo Placebo: Single administration thirty minutes after the start of a high-fat breakfast |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| OG002 | Cohort 3, 8 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| OG003 | Cohort 4, 10 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| OG004 | Cohort 5, 12 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast |
| OG005 | Placebo | A total of 2 subjects per cohort will receive an oral single dose administration of placebo Placebo: Single administration thirty minutes after the start of a high-fat breakfast |
|
|
| Secondary | Maximum Observed Concentration | Cmax (ng/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | Placebo subjects were not included in the PK population. | Posted | Mean | Standard Deviation | ng/mL | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
|
|
|
|
| Secondary | Time of Maximum Observed Concentration | Tmax (hours) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | Placebo subjects were not included in the PK population. | Posted | Median | Full Range | hours | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
|
|
|
| Secondary | Area Under the Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-T) | AUC0-T (ng*h/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | Placebo subjects were not included in the PK population. | Posted | Mean | Standard Deviation | ng*h/mL | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
|
|
|
|
| Secondary | Area Under the Concentration Time Curve Extrapolated to Infinity | AUC0-inf (ng*h/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | Placebo subjects were not included in the PK population. | Posted | Mean | Standard Deviation | ng*h/mL | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
|
|
|
|
| Secondary | Dose-normalized Cmax Calculated at Cmax / Dose | Cmax/D (ng/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | Placebo subjects were not included in the PK population. | Posted | Mean | Standard Deviation | ng/mL/g | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
|
|
|
| Secondary | Dose-normalized AUC0-T Calculated as AUC0-T / Dose | AUC0-T/D (ng*h/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | Placebo subjects were not included in the PK population. | Posted | Mean | Standard Deviation | ng*h/mL/g | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
|
|
|
| Secondary | Dose-normalized AUC0-inf Calculated as AUC0-inf / Dose | AUC0-inf/D (ng*h/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine | Placebo subjects were not included in the PK population. | Posted | Mean | Standard Deviation | (ng*h/mL/g | 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose |
|
|
|
| Secondary | Maximum Effect for Drug Liking | Maximum (peak) effect (Emax) for Drug Liking assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "strong disliking" (score = 0), "neither like nor dislike" (score = 50) to "strong liking" (score = 100). | Posted | Mean | Standard Error | score on a scale (VAS Emax) | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose |
|
|
|
|
| Secondary | Maximum Effect for Overall Drug Liking | Maximum (peak) effect (Emax) for Overall Drug Liking assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "strong disliking" (score = 0), "neither like nor dislike" (score = 50) to "strong liking" (score = 100). | Posted | Mean | Standard Error | score on a scale (VAS EMax) | 12 and 24 hours postdose |
|
|
|
| Secondary | Maximum Effect for Take Drug Again | Maximum (peak) effect (Emax) for Take Drug Again assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "definitely would not" (score = 0), "neither would nor would not" (score = 50) to "definitely would" (score = 100). | Posted | Mean | Standard Error | score on a scale (VAS EMax) | 12 and 24 hours postdose |
|
|
|
| Secondary | Maximum Effect for High | Maximum (peak) effect (Emax) for High assessed on an unipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "not at all" (score = 0) to "extremely" (score = 100). | Posted | Mean | Standard Error | score on a scale (VAS EMax) | Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Cohort 2, 3 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Cohort 3, 8 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | Cohort 4, 10 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast | 0 | 6 | 0 | 6 | 5 | 6 |
| EG004 | Cohort 5, 12 g of Kratom | A total of 6 subjects will receive an oral single dose administration of the active product Kratom: Single administration thirty minutes after the start of a high-fat breakfast | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | Placebo | A total of 2 subjects per cohort will receive an oral single dose administration of placebo Placebo: Single administration thirty minutes after the start of a high-fat breakfast | 0 | 10 | 0 | 10 | 4 | 10 |
|
| Blood pressure systolic increased | Investigations | MedDRA Version 26.1 | Systematic Assessment | Elevated systolic blood pressure. |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment | Pruritus right hand. |
|
| Somnolence | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment | Drowsiness / Feeling sleepy |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment | Emesis |
|
| Leukocyturia | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment | Feeling high. |
|
| Presyncope | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment | Feeling of anxiety. |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment | Diaphoresis |
|
| Feeling hot | General disorders | MedDRA Version 26.1 | Systematic Assessment |
|
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| 7 hydroxy-mitragynine |
|
| Paynantheine |
|
| Speciogynine |
|
| Speciociliatine |
|
Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population) |
| Slope |
| 0.843 |
| 2-Sided |
| 90 |
| 0.713 |
| 0.973 |
| Other |
Proportionality analysis was done using a power model. |
| Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population) | Slope | 0.811 | 2-Sided | 90 | 0.637 | 0.984 | Other | Proportionality analysis was done using a power model. |
| Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population) | Slope | 0.814 | 2-Sided | 90 | 0.633 | 0.994 | Other | Proportionality analysis was done using a power model. |
| Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population) | Slope | 0.880 | 2-Sided | 90 | 0.720 | 1.039 | Other | Proportionality analysis was done using a power model. |
| 7 hydroxy-mitragynine |
|
| paynantheine |
|
| speciogynine |
|
| speciociliatine |
|
| 7 hydroxy-mitragynine |
|
| paynantheine |
|
| speciogynine |
|
| speciociliatine |
|
Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population) |
| Slope |
| 0.978 |
| 2-Sided |
| 90 |
| 0.821 |
| 1.134 |
| Other |
Proportionality analysis was done using a power model. |
| Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population) | Slope | 1.075 | 2-Sided | 90 | 0.901 | 1.249 | Other | Proportionality analysis was done using a power model. |
| Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population) | Slope | 1.046 | 2-Sided | 90 | 0.870 | 1.222 | Other | Proportionality analysis was done using a power model. |
| Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population) | Slope | 1.011 | 2-Sided | 90 | 0.844 | 1.178 | Other | Proportionality analysis was done using a power model. |
| 7 hydroxy-mitragynine |
|
| paynantheine |
|
| speciogynine |
|
| speciociliatine |
|
Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population) |
| Slope |
| 0.974 |
| 2-Sided |
| 90 |
| 0.815 |
| 1.134 |
| Other |
Proportionality analysis was done using a power model. |
| Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population) | Slope | 1.036 | 2-Sided | 90 | 0.866 | 1.207 | Other | Proportionality analysis was done using a power model. |
| Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population) | Slope | 0.967 | 2-Sided | 90 | 0.790 | 1.145 | Other | Proportionality analysis was done using a power model. |
| Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population) | Slope | 1.025 | 2-Sided | 90 | 0.859 | 1.191 | Other | Proportionality analysis was done using a power model. |
| 7 hydroxy-mitragynine |
|
| paynantheine |
|
| speciogynine |
|
| speciociliatine |
|
| 7 hydroxy-mitragynine |
|
| paynantheine |
|
| speciogynine |
|
| speciociliatine |
|
| 7 hydroxy-mitragynine |
|
| paynantheine |
|
| speciogynine |
|
| speciociliatine |
|