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This trial will be a randomised, double-blind, sequential-group, multiple-dose, placebo-controlled, dose escalation trial to characterise the pharmacokinetics (PK), pharmacodynamics (PD) and safety of noribogaine in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noribogaine 20mg | Experimental | 1 x Noribogaine 10mg capsule twice daily |
|
| Noribogaine 40mg | Experimental | 1 x Noribogaine 20mg capsule twice daily |
|
| Noribogaine 60mg | Experimental | 1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily |
|
| Noribogaine 80mg | Experimental | 2 x Noribogaine 20mg capsule twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noribogaine | Drug | Noribogaine capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Cmax Day 1 | Determination of maximum plasma concentration of noribogaine | Day 1 |
| Pharmacokinetics Cmax Day 8 | Determination of maximum plasma concentration of noribogaine | Day 8 |
| Pharmacokinetics Tmax Day 1 | Determination of the time to reach the maximum plasma concentration of noribogaine | Day 1 |
| Pharmacokinetics Tmax Day 8 | Determination of the time to reach the maximum plasma concentration of noribogaine | Day 8 |
| Pharmacokinetics AUC0-t Day 1 | Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine | Day 1 |
| Pharmacokinetics AUC0-t Day 8 | Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine | Day 8 |
| Pharmacokinetics AUC0-infinity Day 8 | Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine | Day 8 |
| Pharmacokinetics t1/2 Day 1 | Determination of elimination half-life (t1/2) of noribogaine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorg Taubel | Richmond Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology | London | United Kingdom |
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All participants enrolled in the study were assigned to a treatment group.
All participants were recruited at a single dedicated site - Richmond Pharmacology.
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| ID | Title | Description |
|---|---|---|
| FG000 | Noribogaine 20mg | 1 x Noribogaine 10mg capsule twice daily |
| FG001 | Noribogaine 40mg | 1 x Noribogaine 20mg capsule twice daily |
| FG002 | Noribogaine 60mg | 1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily |
| FG003 | Noribogaine 80mg | 2 x Noribogaine 20mg capsule twice daily |
| FG004 | Placebo | Placebo capsules twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Noribogaine 20mg | 1 x Noribogaine 10mg capsule twice daily |
| BG001 | Noribogaine 40mg | 1 x Noribogaine 20mg capsule twice daily |
| 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 | Pharmacokinetics Cmax Day 1 | Determination of maximum plasma concentration of noribogaine | Posted | Mean | Standard Deviation | ng/ml | Day 1 |
|
From baseline until end of follow-up, up to 15 days.
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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 | Noribogaine 20mg | 1 x Noribogaine 10mg capsule twice daily | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Richmond Pharmacology | 020 7042 5800 | info@richmondpharmacology.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 | Nov 20, 2024 | Jan 5, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2025 | Jan 5, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C094385 | noribogaine |
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| Day 1 |
| Pharmacokinetics t1/2 Day 8 | Determination of elimination half-life (t1/2) of noribogaine | Day 8 |
| BG002 | Noribogaine 60mg | 1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily |
| BG003 | Noribogaine 80mg | 2 x Noribogaine 20mg capsule twice daily |
| BG004 | Placebo | Placebo capsules twice daily |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| OG003 | Noribogaine 80mg | 2 x Noribogaine 20mg capsule twice daily |
|
|
| Primary | Pharmacokinetics Cmax Day 8 | Determination of maximum plasma concentration of noribogaine | Posted | Mean | Standard Deviation | ng/ml | Day 8 |
|
|
|
| Primary | Pharmacokinetics Tmax Day 1 | Determination of the time to reach the maximum plasma concentration of noribogaine | Posted | Median | Full Range | hours | Day 1 |
|
|
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| Primary | Pharmacokinetics Tmax Day 8 | Determination of the time to reach the maximum plasma concentration of noribogaine | Posted | Median | Full Range | hours | Day 8 |
|
|
|
| Primary | Pharmacokinetics AUC0-t Day 1 | Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine | Insufficient datapoints to determine AUC for the missing participants. | Posted | Mean | Standard Deviation | ng·h/mL | Day 1 |
|
|
|
| Primary | Pharmacokinetics AUC0-t Day 8 | Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine | Posted | Mean | Standard Deviation | ng h/ml | Day 8 |
|
|
|
| Primary | Pharmacokinetics AUC0-infinity Day 8 | Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine | Insufficient datapoints to determine AUC for missing participant. | Posted | Mean | Standard Deviation | ng h/ml | Day 8 |
|
|
|
| Primary | Pharmacokinetics t1/2 Day 1 | Determination of elimination half-life (t1/2) of noribogaine | Insufficient datapoints to calculate Thalf. | Posted | Mean | Standard Deviation | hours | Day 1 |
|
|
|
| Primary | Pharmacokinetics t1/2 Day 8 | Determination of elimination half-life (t1/2) of noribogaine | Posted | Mean | Standard Deviation | hours | Day 8 |
|
|
|
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Noribogaine 40mg | 1 x Noribogaine 20mg capsule twice daily | 0 | 12 | 0 | 12 | 8 | 12 |
| EG002 | Noribogaine 60mg | 1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily | 0 | 12 | 0 | 12 | 11 | 12 |
| EG003 | Noribogaine 80mg | 2 x Noribogaine 20mg capsule twice daily | 0 | 9 | 0 | 9 | 9 | 9 |
| EG004 | Placebo | Placebo capsules twice daily | 0 | 12 | 0 | 12 | 8 | 12 |
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Gastroenteritis viral | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Injection site erythema | General disorders | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
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| Vascular access site bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | Systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dizziness postural | Vascular disorders | Non-systematic Assessment |
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| Presyncope | Vascular disorders | Non-systematic Assessment |
|
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