Trial reportClinical drug investigation2014
Effect of hepatic impairment on the pharmacokinetics of levomilnacipran following a single oral dose of a levomilnacipran extended-release capsule in human participants.
Trial report in Clinical drug investigation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 12 citations in OpenAlex.
- Evaluation of Cytochrome P450 (CYP) 3A4-Based Interactions of Levomilnacipran with Ketoconazole, Carbamazepine or Alprazolam in Healthy Subjects.Clinical drug investigation · 2015Trial
- Disposition and metabolism of [14C]-levomilnacipran, a serotonin and norepinephrine reuptake inhibitor, in humans, monkeys, and rats.Drug design, development and therapy · 2015Trial
- Effect of renal impairment on the pharmacokinetics of levomilnacipran following a single oral dose of levomilnacipran extended-release capsule in humans.Drug design, development and therapy · 2015Trial
- Systemic and Brain Pharmacokinetics of Milnacipran in Mice: Comparison of Intraperitoneal and Intravenous Administration.Pharmaceutics · 2023Article
- The Role of Levomilnacipran in the Management of Major Depressive Disorder: A Comprehensive Review.Current neuropharmacology · 2016Review
- Levomilnacipran extended-release: a review of its use in adult patients with major depressive disorder.CNS drugs · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesLevomilnacipran is a serotonin and norepinephrine reuptake inhibitor with greater potency for the reuptake inhibition of norepinephrine than of serotonin, approved in the USA for the treatment of major depressive disorder (MDD) in adults.
methodsA single-dose, open-label, parallel-group study was conducted to evaluate the effects of hepatic impairment on the pharmacokinetics of levomilnacipran in adults with mild, moderate, or severe hepatic impairment and normal controls receiving a 40 mg levomilnacipran extended-release (ER) capsule. The concentrations of levomilnacipran and its inactive metabolite, N-desethyl levomilnacipran, in plasma and urine were measured using liquid chromatography-tandem mass spectrometry methods. Pharmacokinetic parameters of levomilnacipran and N-desethyl levomilnacipran were derived and assessed. Safety parameters were assessed throughout the trial.
resultsNo deaths, serious adverse events, or discontinuations due to adverse events occurred. The maximum plasma drug concentration (C(max)) and area under the plasma concentration-time curve from time zero to infinity (AUC(∞)) of levomilnacipran were 28 and 32 % higher, respectively, in participants with severe hepatic impairment than in healthy participants without a notable change in the terminal elimination half-life, whereas the C(max) and AUC(∞) of N-desethyl levomilnacipran were 66 and 85 % lower, respectively, suggesting liver function has minimal impact on the overall exposure of levomilnacipran but plays a significant role in the formation of the metabolite.
conclusionsA single dose of levomilnacipran ER 40 mg was generally well-tolerated in participants with varying degrees of hepatic impairment and healthy controls. Therefore, dose adjustment for levomilnacipran is not necessary in adult MDD patients with impaired liver function.
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