Clinical trial: The Effect on Intragastric pH and Pharmacokinetics of the PCAB Linaprazan Glurate in Healthy Subjects After Repeat-Dose Administration for up to 14 Days.
Kajsa Larsson, Kjell Andersson, Gunilla Huledal et al.
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In 30 seconds
This open, randomised, parallel-group Phase 1 trial assessed intragastric pH and pharmacokinetics after single and repeated linaprazan glurate (LG) dosing in 73 healthy subjects. Doses of 25, 50 or 75 mg were given once or twice daily for up to 14 days. After the first dose, intragastric pH exceeded 4 within 60 minutes with 50 mg twice daily and within 10 minutes with 75 mg twice daily. Time at pH > 4 exceeded 90% for both twice-daily doses on Day 1 and 95% on Day 14. LG was reported as safe and well tolerated at the studied doses.
Key findings
- After the first dose, pH > 4 was reached within 60 minutes with 50 mg twice daily and within 10 minutes with 75 mg twice daily.
- Time at pH > 4 exceeded 90% with 50 mg and 75 mg twice daily on Day 1, and 95% on Day 14.
- Time at pH > 4 was higher with 25 mg twice daily than with 50 mg once daily on both Day 1 and Day 14.
- Mean linaprazan AUC and Cmax increased approximately in proportion to LG dose, with no apparent accumulation.
Why it matters
The findings describe how quickly and consistently LG raises gastric pH across studied dosing regimens, alongside its pharmacokinetic profile during repeated administration. This provides early clinical pharmacology information relevant to evaluating the drug, but the study involved healthy subjects and does not establish efficacy for treating oesophageal disease.
What to keep in mind
This Phase 1 study was conducted in healthy subjects and assessed pharmacodynamic and pharmacokinetic outcomes rather than clinical healing or symptom outcomes.