drugset / Trial / NCT05742984

Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects

NCT05742984

Phase 1 Completed 75 enrolled Cinclus Pharma Holding AB
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase I, single-center, open label parallel-group, randomized study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD, by continuous intragastric pH measurment), safety and tolerability of single and repeated oral doses of linaprazan glurate in 3 different dose levels given once- (QD) or twice daily (BID), for 14 days, with an additional single dose after 2, 4 or 6 days of drug holiday. The population will include healthy male and female subjects. The subjects will be followed up to 28 days post IMP dosing.

Timeline

Start
2023-01-26
Primary completion
2023-03-24
Completion
2023-04-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Linaprazan Small molecule 25 mg Oral
Subject Linaprazan Small molecule 50 mg Oral
Subject Linaprazan Small molecule 75 mg Oral