Pharmacokinetics
Conditions
Brief 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.
Interventions
DRUGNoribogaine
Noribogaine capsules
Sponsors
DemeRx NB
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics t1/2 Day 8 | Day 8 | Determination of elimination half-life (t1/2) of noribogaine |
| Pharmacokinetics AUC0-t Day 8 | Day 8 | Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine |
| Pharmacokinetics AUC0-infinity Day 8 | Day 8 | Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine |
| Pharmacokinetics t1/2 Day 1 | Day 1 | Determination of elimination half-life (t1/2) of noribogaine |
| Pharmacokinetics Cmax Day 1 | Day 1 | Determination of maximum plasma concentration of noribogaine |
| Pharmacokinetics Cmax Day 8 | Day 8 | Determination of maximum plasma concentration of noribogaine |
| Pharmacokinetics Tmax Day 1 | Day 1 | Determination of the time to reach the maximum plasma concentration of noribogaine |
| Pharmacokinetics Tmax Day 8 | Day 8 | Determination of the time to reach the maximum plasma concentration of noribogaine |
| Pharmacokinetics AUC0-t Day 1 | Day 1 | Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORJorg Taubel
Richmond Pharmacology
Participant flow
Recruitment details
All participants were recruited at a single dedicated site - Richmond Pharmacology.
Pre-assignment details
All participants enrolled in the study were assigned to a treatment group.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.1 Years STANDARD_DEVIATION 6.12 |
| BMI | 22.5 kg/m2 STANDARD_DEVIATION 3.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United Kingdom | 12 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 | 0 / 12 | 0 / 9 | 0 / 12 |
| other Total, other adverse events | 4 / 10 | 8 / 12 | 11 / 12 | 9 / 9 | 8 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 | 0 / 12 | 0 / 9 | 0 / 12 |
Outcome results
None listed