Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers

A Phase 1 study testing Noribogaine in people with Pharmacokinetics, run by DemeRx NB at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: Noribogaine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited Kingdom
Study dates: 20 Jun 2024to 13 Jan 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Ability to provide written, personally signed, and dated informed consent.
Healthy male and female participants between the ages of 18 to 45 inclusive.
BMI 18 - 30 kg/m2.
Non- or ex-smoker.
Normal ECG findings i.e. QTcF interval ≤ 450 ms and normal morphology that would permit accurate assessment of the QT interval.
Participants must agree to use highly

Who cannot join

History of, or concurrent clinically significant cardiovascular, dysautonomia, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study.
Family history in first degree relatives for unknown and/or known arrhythmia-related cardiac events, cardiomyopathy, syncope, long QT syndrome, Brugada's syndrome, sudden death attributed to cardiac causes, and familial cardiac channelopathies.
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with interpretation of QTc interval changes.
Previous or current alcohol, or other drug dependence.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Richmond Pharmacology
London

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Multiple Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ascending Doses of Noribogaine in Healthy Volunteers.

Conditions: Pharmacokinetics
Being tested: Noribogaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NoribogaineDrug
Noribogaine capsules

Study groups in NCT06480981
Study group	Role	What they receive
Noribogaine 20mg	Experimental	1 x Noribogaine 10mg capsule twice daily Receives: Drug: Noribogaine
Noribogaine 40mg	Experimental	1 x Noribogaine 20mg capsule twice daily Receives: Drug: Noribogaine
Noribogaine 60mg	Experimental	1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily Receives: Drug: Noribogaine
Noribogaine 80mg	Experimental	2 x Noribogaine 20mg capsule twice daily Receives: Drug: Noribogaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics Cmax Day 1
Determination of maximum plasma concentration of noribogaine
Measured: Day 1
Pharmacokinetics Cmax Day 8
Determination of maximum plasma concentration of noribogaine
Measured: Day 8
Pharmacokinetics Tmax Day 1
Determination of the time to reach the maximum plasma concentration of noribogaine
Measured: Day 1
Pharmacokinetics Tmax Day 8
Determination of the time to reach the maximum plasma concentration of noribogaine
Measured: Day 8
Pharmacokinetics AUC0-t Day 1
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Measured: Day 1
Pharmacokinetics AUC0-t Day 8
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Measured: Day 8
Pharmacokinetics AUC0-infinity Day 8
Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine
Measured: Day 8
Pharmacokinetics t1/2 Day 1
Determination of elimination half-life (t1/2) of noribogaine
Measured: Day 1
Pharmacokinetics t1/2 Day 8
Determination of elimination half-life (t1/2) of noribogaine
Measured: Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 202413 Jan 2025

First posted1 Jul 2024
Study start20 Jun 2024
Primary completion23 Dec 2024
Study completion13 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharmacokineticsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06480981
Sponsor's protocol ID: DMX-NB-001
Status last verified: Jan 2026
First submitted: 19 Jun 2024
Last updated: 22 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pharmacokinetics trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Multiple Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ascending Doses of Noribogaine in Healthy Volunteers.
ClinicalTrials.gov ID: NCT06480981
Acronym / sponsor ID: DMX-NB-001
Conditions: Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: DemeRx NBIndustry (pharma, biotech, devices)
Study start: 20 Jun 2024 (actual)
Primary completion: 23 Dec 2024 (actual)
Study completion: 13 Jan 2025 (actual)
First posted: 1 Jul 2024 (actual)
Results: Posted 22 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Noribogaine 20mg	Experimental	Drug: Noribogaine1 x Noribogaine 10mg capsule twice daily
Noribogaine 40mg	Experimental	Drug: Noribogaine1 x Noribogaine 20mg capsule twice daily
Noribogaine 60mg	Experimental	Drug: Noribogaine1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
Noribogaine 80mg	Experimental	Drug: Noribogaine2 x Noribogaine 20mg capsule twice daily

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Ability to provide written, personally signed, and dated informed consent.
Healthy male and female participants between the ages of 18 to 45 inclusive.
BMI 18 - 30 kg/m2.
Non- or ex-smoker.
Normal ECG findings i.e. QTcF interval ≤ 450 ms and normal morphology that would permit accurate assessment of the QT interval.

Key exclusion criteria (4 listed)

History of, or concurrent clinically significant cardiovascular, dysautonomia, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study.
Family history in first degree relatives for unknown and/or known arrhythmia-related cardiac events, cardiomyopathy, syncope, long QT syndrome, Brugada's syndrome, sudden death attributed to cardiac causes, and familial cardiac channelopathies.
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with interpretation of QTc interval changes.
Previous or current alcohol, or other drug dependence.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NoribogaineNoribogaine capsules	Drug	Noribogaine 20mg, Noribogaine 40mg, Noribogaine 60mg, Noribogaine 80mg

Primary outcome

Pharmacokinetics Cmax Day 1
Time frame: Day 1
Determination of maximum plasma concentration of noribogaine
Pharmacokinetics Cmax Day 8
Time frame: Day 8
Determination of maximum plasma concentration of noribogaine
Pharmacokinetics Tmax Day 1
Time frame: Day 1
Determination of the time to reach the maximum plasma concentration of noribogaine
Pharmacokinetics Tmax Day 8
Time frame: Day 8
Determination of the time to reach the maximum plasma concentration of noribogaine
Pharmacokinetics AUC0-t Day 1
Time frame: Day 1
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Pharmacokinetics AUC0-t Day 8
Time frame: Day 8
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Pharmacokinetics AUC0-infinity Day 8
Time frame: Day 8
Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine
Pharmacokinetics t1/2 Day 1
Time frame: Day 1
Determination of elimination half-life (t1/2) of noribogaine
Pharmacokinetics t1/2 Day 8
Time frame: Day 8
Determination of elimination half-life (t1/2) of noribogaine

Results and safety

Results posted to the registry on 22 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Noribogaine 20mg	10	10
Noribogaine 40mg	12	12
Noribogaine 60mg	12	12
Noribogaine 80mg	9	9
Placebo	12	12

Primary outcome: Pharmacokinetics Cmax Day 1

Time frame: Day 1. Mean (Standard Deviation). Unit: ng/ml

Measure	Noribogaine 20mg n = 10	Noribogaine 40mg n = 12	Noribogaine 60mg n = 12	Noribogaine 80mg n = 9
Value	10.4 (3.26)	22.7 (8.47)	39.5 (8.27)	45.2 (10.5)

Primary outcome: Pharmacokinetics Cmax Day 8

Time frame: Day 8. Mean (Standard Deviation). Unit: ng/ml

Measure	Noribogaine 20mg n = 10	Noribogaine 40mg n = 12	Noribogaine 60mg n = 12	Noribogaine 80mg n = 9
Value	28.7 (13.1)	45.5 (19.7)	91.9 (30.6)	113 (27.9)

Primary outcome: Pharmacokinetics Tmax Day 1

Time frame: Day 1. Median (Full Range). Unit: hours

Measure	Noribogaine 20mg n = 10	Noribogaine 40mg n = 12	Noribogaine 60mg n = 12	Noribogaine 80mg n = 9
Value	4.01 (2.5 to 8)	2.75 (1.5 to 8.03)	3.27 (2 to 8.07)	3.50 (1.5 to 8.07)

Primary outcome: Pharmacokinetics Tmax Day 8

Time frame: Day 8. Median (Full Range). Unit: hours

Measure	Noribogaine 20mg n = 10	Noribogaine 40mg n = 12	Noribogaine 60mg n = 12	Noribogaine 80mg n = 9
Value	3.5 (1.5 to 4.0)	1.87 (1.0 to 3.53)	2.53 (1.5 to 4.0)	3.0 (1.0 to 4.0)

Adverse events

Time frame: From baseline until end of follow-up, up to 15 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Noribogaine 20mg	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Noribogaine 40mg	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12
Noribogaine 60mg	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
Noribogaine 80mg	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Placebo	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pharmacokinetics

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Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jorg Taubel principal investigator

Richmond Pharmacology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Noribogaine in people with Pharmacokinetics, run by DemeRx NB at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics Cmax Day 1 (time frame: Day 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06480981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.