Investigation of the Differences in the Pharmacokinetics of CYP2D6 Substrates, Desipramine, and Dextromethorphan in Healthy African Subjects Carrying the Allelic Variants CYP2D6*17 and CYP2D6*29, When Compared with Normal Metabolizers.

This study investigated the differences in the pharmacokinetics (PK) of dextromethorphan and desipramine in healthy African volunteers to understand the effect of allelic variants of the human cytochrome P450 2D6 (CYP2D6) enzyme, namely the diplotypes of CYP2D6*1/*2 (*1*1, *1*2, *2*2) and the genoty...

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Published in:Journal of Clinical Pharmacology Vol. 64; no. 5; pp. 578 - 590
Main Authors: Marasanapalle, Venugopal P., Masimirembwa, Collen, Sivasubramanian, Rama, Sayyed, Sarfaraz, Weinzierl‐Hinum, Armin, Mehta, Dheeraj, Kapungu, Nyasha Nicole, Kanji, Comfort, Thelingwani, Roslyn, Zack, Julia
Format: research tables/charts Journal Article
Published: Wiley-Blackwell May2024
Online Access:View this record in EBSCOhost
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      dt: May2024
      vid: 64
      iid: 5
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        176813476
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        176813476
        176813476
        10.1002/jcph.2366
        176813476
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        atl: Investigation of the Differences in the Pharmacokinetics of CYP2D6 Substrates, Desipramine, and Dextromethorphan in Healthy African Subjects Carrying the Allelic Variants CYP2D6*17 and CYP2D6*29, When Compared with Normal Metabolizers.
      aug:
        au:
          Marasanapalle, Venugopal P.
          Masimirembwa, Collen
          Sivasubramanian, Rama
          Sayyed, Sarfaraz
          Weinzierl‐Hinum, Armin
          Mehta, Dheeraj
          Kapungu, Nyasha Nicole
          Kanji, Comfort
          Thelingwani, Roslyn
          Zack, Julia
        affil: Novartis Healthcare Private Limited, Hyderabad, India
      sug:
        subj:
          Antidepressive Agents, Tricyclic Blood
          Antidepressive Agents, Tricyclic Pharmacokinetics
          Oxidoreductases Metabolism
          Black Africans
          Human
          Genetic Profile
          Male
          Female
          Funding Source
          Pharmacogenetics
          Descriptive Statistics
          Confidence Intervals
          Male
          Female
      ab: This study investigated the differences in the pharmacokinetics (PK) of dextromethorphan and desipramine in healthy African volunteers to understand the effect of allelic variants of the human cytochrome P450 2D6 (CYP2D6) enzyme, namely the diplotypes of CYP2D6*1/*2 (*1*1, *1*2, *2*2) and the genotypes of CYP2D6*17*17 and CYP2D6*29*29. Overall, 28 adults were included and split into 3 cohorts after genotype screening: CYP2D6*1/*2 (n = 12), CYP2D6*17*17 (n = 12), and CYP2D6*29*29 (n = 4). Each subject received a single oral dose of dextromethorphan 30 mg syrup on day 1 and desipramine 50 mg tablet on day 8. The PK parameters of area under the plasma concentration‐time curve from time of dosing to time of last quantifiable concentration (AUClast), and extrapolated to infinity (AUCinf), and the maximum plasma concentration (Cmax) were determined. For both dextromethorphan and desipramine, AUCinf and Cmax were higher in subjects of the CYP2D6*29*29 and CYP2D6*17*17 cohorts, as compared with subjects in the CYP2D6*1/*2 diplotype cohort and with normal metabolizers from the literature. All PK parameters, including AUCinf, Cmax, and the elimination half‐life, followed a similar trend: CYP2D6*17*17 > CYP2D6*29*29 > CYP2D6*1/*2. The plasma and urinary drug/metabolite exposure ratios of both drugs were higher in subjects of the CYP2D6*17*17 and CYP2D6*29*29 cohorts, when compared with subjects in the CYP2D6*1/*2 diplotype cohort. All adverse events were mild, except in 1 subject with CYP2D6*17*17 who had moderately severe headache with desipramine. These results indicate that subjects with CYP2D6*17*17 and CYP2D6*29*29 genotypes were 5‐10 times slower metabolizers than those with CYP2D6*1/*2 diplotypes. These findings suggest that dose optimization may be required when administering CYP2D6 substrate drugs in African patients. Larger studies can further validate these findings.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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