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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
55
Noribogaine capsules
Richmond Pharmacology
London, United Kingdom
Pharmacokinetics Cmax Day 1
Determination of maximum plasma concentration of noribogaine
Time frame: Day 1
Pharmacokinetics Cmax Day 8
Determination of maximum plasma concentration of noribogaine
Time frame: Day 8
Pharmacokinetics Tmax Day 1
Determination of the time to reach the maximum plasma concentration of noribogaine
Time frame: Day 1
Pharmacokinetics Tmax Day 8
Determination of the time to reach the maximum plasma concentration of noribogaine
Time frame: Day 8
Pharmacokinetics AUC0-t Day 1
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Time frame: Day 1
Pharmacokinetics AUC0-t Day 8
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Time frame: Day 8
Pharmacokinetics AUC0-infinity Day 8
Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine
Time frame: Day 8
Pharmacokinetics t1/2 Day 1
Determination of elimination half-life (t1/2) of noribogaine
Time frame: Day 1
Pharmacokinetics t1/2 Day 8
Determination of elimination half-life (t1/2) of noribogaine
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Time frame: Day 8