Safety, pharmacokinetics, and pharmacodynamics of TV-1380, a novel mutated butyrylcholinesterase treatment for cocaine addiction, after single and multiple intramuscular injections in healthy subjects.
Bottom Line: Two randomized, blinded phase I studies were conducted to evaluate the safety, pharmacokinetics, and pharmacodynamics of TV-1380, following single and multiple administration in healthy subjects.TV-1380 was found to be safe and well tolerated with a long half-life (43-77 hours) and showed a dose-proportional increase in systemic exposure.There was no evidence that TV-1380 affected heart rate, the uncorrected QT interval, or the heart-rate-corrected QTcF interval.
Affiliation: Teva Pharmaceuticals, Inc., Netanya, Israel.Show MeSH
Related in: MedlinePlus
Mentions: Dose-normalized Cmax and AUCtau at 50 mg (Figure 3 panels a and b) appeared to be slightly higher than for 150 and 300 mg, possibly due to the associated lower TV-1380 concentrations and the resulting missing data at this dose level. It was, however, concluded that exposure to TV-1380 increased in a dose-proportional manner both after single and multiple dosing.