Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers

DemeRx NB

Status and phase: Enrolling; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Noribogaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06480981

DMX-NB-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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60 participants in 4 patient groups

Noribogaine 20mg

Experimental group

Description:

1 x Noribogaine 10mg capsule twice daily

Treatment:

Drug: Noribogaine

Noribogaine 40mg

Experimental group

Description:

1 x Noribogaine 20mg capsule twice daily

Treatment:

Drug: Noribogaine

Noribogaine 60mg

Experimental group

Description:

1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily

Treatment:

Drug: Noribogaine

Noribogaine 80mg

Experimental group

Description:

2 x Noribogaine 20mg capsule twice daily

Treatment:

Drug: Noribogaine