A population PK-PD model of YH4808, a novel P-CAB, and intragastric pH that incorporated negative feedback by increased intragastric pH onto the systemic exposure to YH4808.

ABSTRACT: YH4808 is a novel potassium-competitive acid blocker that is under clinical development to treat patients with gastroesophageal reflux disease and peptic ulcer diseases. In this study, the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of YH4808 were modeled in healthy male volunteers who received a single oral dose of YH4808 at 30, 50, 100, 200, 400, 600, and 800 mg or matching placebo and multiple once-daily oral doses of YH4808 at 100, 200, and 400 mg or matching placebo for 7 days. A population PK-PD model adequately described the time-concentration-effect profiles of YH4808. The maximum increasing effect of YH4808 on intragastric pH was 4.38, which was higher than the observed maximum increase in intragastric pH after omeprazole at 40 mg (2.2 in pH). The maximum inhibitory eff

SUBMITTER: Chung TK 

PROVIDER: S-EPMC9469698 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature