drugset / Trial / NCT05742984
Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linaprazan | Small molecule | 25 mg | Oral |
| Subject | Linaprazan | Small molecule | 50 mg | Oral |
| Subject | Linaprazan | Small molecule | 75 mg | Oral |