Trial Outcomes & Findings for Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers (NCT NCT06480981)
NCT ID: NCT06480981
Last Updated: 2026-01-22
Results Overview
Determination of maximum plasma concentration of noribogaine
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
55 participants
Primary outcome timeframe
Day 1
Results posted on
2026-01-22
Participant Flow
All participants were recruited at a single dedicated site - Richmond Pharmacology.
All participants enrolled in the study were assigned to a treatment group.
Participant milestones
| Measure |
Noribogaine 20mg
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
2 x Noribogaine 20mg capsule twice daily
|
Placebo
Placebo capsules twice daily
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
12
|
9
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
12
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Noribogaine 20mg
n=10 Participants
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=12 Participants
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=12 Participants
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=9 Participants
2 x Noribogaine 20mg capsule twice daily
|
Placebo
n=12 Participants
Placebo capsules twice daily
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.0 Years
STANDARD_DEVIATION 5.14 • n=270 Participants
|
28.7 Years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
31.1 Years
STANDARD_DEVIATION 6.96 • n=9 Participants
|
29.1 Years
STANDARD_DEVIATION 4.91 • n=220 Participants
|
29.3 Years
STANDARD_DEVIATION 5.5 • n=3 Participants
|
29.1 Years
STANDARD_DEVIATION 6.12 • n=18 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
3 Participants
n=220 Participants
|
4 Participants
n=3 Participants
|
20 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=270 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
6 Participants
n=220 Participants
|
8 Participants
n=3 Participants
|
35 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
4 Participants
n=3 Participants
|
14 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
7 Participants
n=220 Participants
|
4 Participants
n=3 Participants
|
21 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
3 Participants
n=3 Participants
|
16 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=18 Participants
|
|
Region of Enrollment
United Kingdom
|
10 Participants
n=270 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=9 Participants
|
9 Participants
n=220 Participants
|
12 Participants
n=3 Participants
|
55 Participants
n=18 Participants
|
|
BMI
|
22.5 kg/m2
STANDARD_DEVIATION 3.1 • n=270 Participants
|
23.9 kg/m2
STANDARD_DEVIATION 2.36 • n=4 Participants
|
23.2 kg/m2
STANDARD_DEVIATION 2.45 • n=9 Participants
|
24.6 kg/m2
STANDARD_DEVIATION 3.01 • n=220 Participants
|
24.9 kg/m2
STANDARD_DEVIATION 2.35 • n=3 Participants
|
23.8 kg/m2
STANDARD_DEVIATION 2.68 • n=18 Participants
|
PRIMARY outcome
Timeframe: Day 1Determination of maximum plasma concentration of noribogaine
Outcome measures
| Measure |
Noribogaine 20mg
n=10 Participants
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=12 Participants
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=12 Participants
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=9 Participants
2 x Noribogaine 20mg capsule twice daily
|
|---|---|---|---|---|
|
Pharmacokinetics Cmax Day 1
|
10.4 ng/ml
Standard Deviation 3.26
|
22.7 ng/ml
Standard Deviation 8.47
|
39.5 ng/ml
Standard Deviation 8.27
|
45.2 ng/ml
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: Day 8Determination of maximum plasma concentration of noribogaine
Outcome measures
| Measure |
Noribogaine 20mg
n=10 Participants
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=12 Participants
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=12 Participants
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=9 Participants
2 x Noribogaine 20mg capsule twice daily
|
|---|---|---|---|---|
|
Pharmacokinetics Cmax Day 8
|
28.7 ng/ml
Standard Deviation 13.1
|
45.5 ng/ml
Standard Deviation 19.7
|
91.9 ng/ml
Standard Deviation 30.6
|
113 ng/ml
Standard Deviation 27.9
|
PRIMARY outcome
Timeframe: Day 1Determination of the time to reach the maximum plasma concentration of noribogaine
Outcome measures
| Measure |
Noribogaine 20mg
n=10 Participants
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=12 Participants
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=12 Participants
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=9 Participants
2 x Noribogaine 20mg capsule twice daily
|
|---|---|---|---|---|
|
Pharmacokinetics Tmax Day 1
|
4.01 hours
Interval 2.5 to 8.0
|
2.75 hours
Interval 1.5 to 8.03
|
3.27 hours
Interval 2.0 to 8.07
|
3.50 hours
Interval 1.5 to 8.07
|
PRIMARY outcome
Timeframe: Day 8Determination of the time to reach the maximum plasma concentration of noribogaine
Outcome measures
| Measure |
Noribogaine 20mg
n=10 Participants
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=12 Participants
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=12 Participants
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=9 Participants
2 x Noribogaine 20mg capsule twice daily
|
|---|---|---|---|---|
|
Pharmacokinetics Tmax Day 8
|
3.5 hours
Interval 1.5 to 4.0
|
1.87 hours
Interval 1.0 to 3.53
|
2.53 hours
Interval 1.5 to 4.0
|
3.0 hours
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: Day 1Population: Insufficient datapoints to determine AUC for the missing participants.
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Outcome measures
| Measure |
Noribogaine 20mg
n=6 Participants
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=8 Participants
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=9 Participants
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=5 Participants
2 x Noribogaine 20mg capsule twice daily
|
|---|---|---|---|---|
|
Pharmacokinetics AUC0-t Day 1
|
87.8 ng·h/mL
Standard Deviation 40.1
|
196 ng·h/mL
Standard Deviation 48.0
|
335 ng·h/mL
Standard Deviation 92.2
|
414 ng·h/mL
Standard Deviation 72.6
|
PRIMARY outcome
Timeframe: Day 8Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Outcome measures
| Measure |
Noribogaine 20mg
n=10 Participants
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=12 Participants
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=12 Participants
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=9 Participants
2 x Noribogaine 20mg capsule twice daily
|
|---|---|---|---|---|
|
Pharmacokinetics AUC0-t Day 8
|
289 ng h/ml
Standard Deviation 152
|
429 ng h/ml
Standard Deviation 215
|
847 ng h/ml
Standard Deviation 329
|
1030 ng h/ml
Standard Deviation 275
|
PRIMARY outcome
Timeframe: Day 8Population: Insufficient datapoints to determine AUC for missing participant.
Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine
Outcome measures
| Measure |
Noribogaine 20mg
n=9 Participants
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=12 Participants
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=12 Participants
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=9 Participants
2 x Noribogaine 20mg capsule twice daily
|
|---|---|---|---|---|
|
Pharmacokinetics AUC0-infinity Day 8
|
934 ng h/ml
Standard Deviation 675
|
974 ng h/ml
Standard Deviation 679
|
2200 ng h/ml
Standard Deviation 1330
|
2550 ng h/ml
Standard Deviation 1210
|
PRIMARY outcome
Timeframe: Day 1Population: Insufficient datapoints to calculate Thalf.
Determination of elimination half-life (t1/2) of noribogaine
Outcome measures
| Measure |
Noribogaine 20mg
n=6 Participants
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=6 Participants
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=9 Participants
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=4 Participants
2 x Noribogaine 20mg capsule twice daily
|
|---|---|---|---|---|
|
Pharmacokinetics t1/2 Day 1
|
13.8 hours
Standard Deviation 4.2
|
10.5 hours
Standard Deviation 4.52
|
9.59 hours
Standard Deviation 2.38
|
11.5 hours
Standard Deviation 3.16
|
PRIMARY outcome
Timeframe: Day 8Determination of elimination half-life (t1/2) of noribogaine
Outcome measures
| Measure |
Noribogaine 20mg
n=10 Participants
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=12 Participants
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=12 Participants
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=9 Participants
2 x Noribogaine 20mg capsule twice daily
|
|---|---|---|---|---|
|
Pharmacokinetics t1/2 Day 8
|
23.0 hours
Standard Deviation 11.3
|
14.0 hours
Standard Deviation 4.34
|
28.4 hours
Standard Deviation 19.7
|
25.4 hours
Standard Deviation 12.1
|
Adverse Events
Noribogaine 20mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Noribogaine 40mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Noribogaine 60mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Noribogaine 80mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Noribogaine 20mg
n=10 participants at risk
1 x Noribogaine 10mg capsule twice daily
|
Noribogaine 40mg
n=12 participants at risk
1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 60mg
n=12 participants at risk
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
|
Noribogaine 80mg
n=9 participants at risk
2 x Noribogaine 20mg capsule twice daily
|
Placebo
n=12 participants at risk
Placebo capsules twice daily
|
|---|---|---|---|---|---|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
16.7%
2/12 • From baseline until end of follow-up, up to 15 days.
|
50.0%
6/12 • From baseline until end of follow-up, up to 15 days.
|
77.8%
7/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
16.7%
2/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
8.3%
1/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
11.1%
1/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
8.3%
1/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.0%
1/10 • From baseline until end of follow-up, up to 15 days.
|
50.0%
6/12 • From baseline until end of follow-up, up to 15 days.
|
75.0%
9/12 • From baseline until end of follow-up, up to 15 days.
|
55.6%
5/9 • From baseline until end of follow-up, up to 15 days.
|
66.7%
8/12 • From baseline until end of follow-up, up to 15 days.
|
|
Vascular disorders
Dizziness postural
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
8.3%
1/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Vascular disorders
Presyncope
|
10.0%
1/10 • From baseline until end of follow-up, up to 15 days.
|
16.7%
2/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
22.2%
2/9 • From baseline until end of follow-up, up to 15 days.
|
8.3%
1/12 • From baseline until end of follow-up, up to 15 days.
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
10.0%
1/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
8.3%
1/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
8.3%
1/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
8.3%
1/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
11.1%
1/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
8.3%
1/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
22.2%
2/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
8.3%
1/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
8.3%
1/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
|
General disorders
Injection site erythema
|
10.0%
1/10 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/9 • From baseline until end of follow-up, up to 15 days.
|
0.00%
0/12 • From baseline until end of follow-up, up to 15 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place