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Safety, pharmacokinetics, and pharmacodynamics of TV-1380, a novel mutated butyrylcholinesterase treatment for cocaine addiction, after single and multiple intramuscular injections in healthy subjects.

Cohen-Barak O, Wildeman J, van de Wetering J, Hettinga J, Schuilenga-Hut P, Gross A, Clark S, Bassan M, Gilgun-Sherki Y, Mendzelevski B, Spiegelstein O - J Clin Pharmacol (2015)

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.

View Article: PubMed Central - PubMed

Affiliation: Teva Pharmaceuticals, Inc., Netanya, Israel.

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Related in: MedlinePlus

Individual and geometric mean dose-normalized TV-1380 Cmax and AUC0–tau on Days 1 and 22.
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fig03: Individual and geometric mean dose-normalized TV-1380 Cmax and AUC0–tau on Days 1 and 22.

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.


Safety, pharmacokinetics, and pharmacodynamics of TV-1380, a novel mutated butyrylcholinesterase treatment for cocaine addiction, after single and multiple intramuscular injections in healthy subjects.

Cohen-Barak O, Wildeman J, van de Wetering J, Hettinga J, Schuilenga-Hut P, Gross A, Clark S, Bassan M, Gilgun-Sherki Y, Mendzelevski B, Spiegelstein O - J Clin Pharmacol (2015)

Individual and geometric mean dose-normalized TV-1380 Cmax and AUC0–tau on Days 1 and 22.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4402032&req=5

fig03: Individual and geometric mean dose-normalized TV-1380 Cmax and AUC0–tau on Days 1 and 22.
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.

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.

View Article: PubMed Central - PubMed

Affiliation: Teva Pharmaceuticals, Inc., Netanya, Israel.

Show MeSH
Related in: MedlinePlus