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S470 Development and Utilization of a Pharmacokinetic/Pharmacodynamic Model for Vonoprazan to Assess the Relationship Between Dose, Exposure, and pH Holding Time Ratio

The American journal of gastroenterology, 2022-10, Vol.117 (10S), p.e333-e333 [Peer Reviewed Journal]

2022 by The American College of Gastroenterology ;ISSN: 0002-9270 ;EISSN: 1572-0241 ;DOI: 10.14309/01.ajg.0000858520.42778.08

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  • Title:
    S470 Development and Utilization of a Pharmacokinetic/Pharmacodynamic Model for Vonoprazan to Assess the Relationship Between Dose, Exposure, and pH Holding Time Ratio
  • Author: Scarpignato, Carmelo ; Howden, Colin W. ; Leifke, Eckhard ; Mulford, Darcy J. ; Lahu, Gezim ; Facius, Axel ; Hunt, Richard
  • Subjects: Estimates ; Gastroenterology ; Pharmacodynamics ; Pharmacokinetics
  • Is Part Of: The American journal of gastroenterology, 2022-10, Vol.117 (10S), p.e333-e333
  • Description: The models were used to simulate pH HTRs with between-subject variability; results were summarized as mean and 80% prediction intervals. The estimates and 95% confidence intervals for all model parameters are shown in Table. Estimates and 95% CIs for Model Parameters Parameter Role pH >4 Estimate (95% CI) pH >5 Estimate (95% CI) pH >6 Estimate (95% CI) E0 TV (logit) -2.74 (3.77%) (-2.84 to -2.64) -3.18 (1.56%) (-3.27 to -3.09) -3.48 (0.514%) (-3.54 to -3.42) Asian-effect (%) -12.8 (-17.3 to -8.41) -9.23 (-12.7 to -5.74) -5.63 (-8.11 to -3.15) BSV 0.388 (0.310 to 0.465) 0.276 (0.192 to 0.361) 3.16e-05 (-0.286 to 0.286) EC50 TV (ng/mL) 48.2 (43.9 to 52.4) 58.8 (53.1 to 64.5) 99.5 (86.2 to 113) gamma 1.39 (1.20 to 1.58) 1.34 (1.17 to 1.52) 1.62 (1.30 to 1.94) Weight effect (1/kg) 1.50 (0.803 to 2.19) 1.81 (1.19 to 2.44) - BSV 0.319 (0.259 to 0.379) 0.310 (0.252 to 0.368) 0.235 (0.102 to 0.368) Emax TV (logit) 4.80 (102%) (4.53 to 5.07) 4.83 (102%) (4.44 to 5.23) 2.17 (91.9%) (1.65 to 2.70) Weight effect (1/kg) - - -0.0187 (-0.0265 to -0.0108) BSV 1e-04 (6.80e-05 to 0.000132) 1e-04 (5.42e-05 to 0.000146) 0.781 (0.505 to 1.06) ET50 TV (days) 0.432 (0.384 to 0.481) 0.427 (0.369 to 0.485) 0.348 (0.274 to 0.422) delta 1 (fixed) 1 (fixed) 1 (fixed) RUV add.err. (logit) 0.528 (0.475 to 0.580) 0.545 (0.493 to 0.596) 0.498 (0.457 to 0.539) E0 and Emax were estimated on the logit-scale as the pH holding time ratios were logit-transformed; back-transformed estimates on the original percent scale are given for these parameters in round brackets. add.err., additive error; BSV, between subject variability; CI, confidence interval; E0, baseline effect; Emax, theoretical maximum effect achieved at infinite exposure and time; EC50, exposure (AUC) required to achieve 50% of maximum effect (Emax); ET50, time required to achieve 50% of maximum effect; RUV, residual unexplained variability; TV, typical value.
  • Publisher: New York: Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
  • Language: English
  • Identifier: ISSN: 0002-9270
    EISSN: 1572-0241
    DOI: 10.14309/01.ajg.0000858520.42778.08
  • Source: AUTh Library subscriptions: ProQuest Central
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