drugset / Trial / NCT04293965
Single-dose and Multiple-dose X842 Phase 1 Study
Non-randomizedSequentialOpen-labelBasic science
Summary
The purpose of this study is to evaluate the safety and tolerability of X842 after administration of single and multiple doses in healthy subjects
Timeline
- Start
- 2018-10-23
- Primary completion
- 2019-09-04
- Completion
- 2019-09-04
Publications
- Background El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13.
- Background Yuan Y, Hunt RH. Evolving issues in the management of reflux disease? Curr Opin Gastroenterol. 2009 Jul;25(4):342-51. doi: 10.1097/MOG.0b013e32832c1504.
- Background Dent J, Kahrilas PJ, Hatlebakk J, Vakil N, Denison H, Franzen S, Lundborg P. A randomized, comparative trial of a potassium-competitive acid blocker (AZD0865) and esomeprazole for the treatment of patients with nonerosive reflux disease. Am J Gastroenterol. 2008 Jan;103(1):20-6. doi: 10.1111/j.1572-0241.2007.01544.x.
- Background Kahrilas PJ, Dent J, Lauritsen K, Malfertheiner P, Denison H, Franzen S, Hasselgren G. A randomized, comparative study of three doses of AZD0865 and esomeprazole for healing of reflux esophagitis. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1385-91. doi: 10.1016/j.cgh.2007.08.014. Epub 2007 Oct 22.
- Background Nilsson, Albrektson E, Rydholm H, Rohss K, Alin MH, Hasselgren G. Tolerability, Pharmacokinetics and Effects on Gastric Acid Secretion After Single Oral Doses of the Potassium-Competitive Acid Blocker (P-CAB) AZD0865 in Healthy Male Subjects. Gastroenterology 2005 Volume 128, Issue 4, Supplement 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linaprazan glurate | Small molecule | 5.6 mg | — |
| Subject | Linaprazan glurate | Small molecule | 12.5 mg | — |
| Subject | Linaprazan glurate | Small molecule | 25 mg | — |
| Subject | Linaprazan glurate | Small molecule | 50 mg | — |
| Subject | Linaprazan glurate | Small molecule | 100 mg | — |
| Subject | Linaprazan glurate | Small molecule | 150 mg | — |
| Subject | Linaprazan glurate | Small molecule | 225 mg | — |
Indications
No indication recorded.