Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1722 salt · 1 trial · 1 indication
Sodium and phosphorus content in stool collected over 24-hour intervals
| Arm | Type | Description |
|---|---|---|
| Treatment A AZD1722 salt tablet (fasted) | EXPERIMENTAL | Part A-Treatment A: morning dose of AZD1722 salt tablet 5 to 10 minutes before start of intake of breakfast; evening dose 5 to 10 minutes before start of intake of dinner |
| Treatment B AZD1722 salt tablet (fed) | EXPERIMENTAL | Part A Treatment B: morning dose of AZD1722 salt tablet 30 minutes after start of intake of breakfast; evening dose 30 minutes after start of intake of dinner |
| Treatment C AZD1722 salt tablet (fasted) | EXPERIMENTAL | Part A Treatment C: morning dose AZD1722 HCl tablet then breakfast served 1 hour after dosing; evening dose 3 hours after start of intake of dinner and 1 hour before the next meal consumption |
| Treat D AZD1722 free-base tablet (fast) | EXPERIMENTAL | Part B Treatment D: morning dose of AZD1722 free-base tablet administered 5 to 10 minutes before the start of intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner |
| Treat E AZD1722 free-base+Omeprazole | EXPERIMENTAL | Part B Treatment E: morning dose of AZD1722 free base tablet administered 5 to 10 minutes before start of intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner; omeprazole was administered twice daily from Days -5 to -1 or Days 5 to 9 (depending on assigned treatment period), 1 hour before breakfast and dinner, and from Days 1 to 4 or Days 10 to 13, 1 hour prior to the administration of AZD1722 |
| Name | Type | Description |
|---|---|---|
| AZD1722 salt tablet | DRUG | AZD1722 will be administered as 14 mg (salt tablet). tablet for oral use. Subjects will receive a 14 mg tablet in the morning and evening on Days 1 to 4 (Period 1), Days 7 to 10 (Period 2), and Days 13 to 16 (Period 3). |
| AZD1722 free base tablet | DRUG | AZD1722 will be given as four 14 mg free-base tablets (56mg) in the morning and evening on Days 1 to 4 (Period 1) and Days 10 to 13 (Period 2). |
| AZD1722 free base tablet + Omeprazole | DRUG | AZD1722 free base tablet administered 5 to 10 minutes before intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner; omeprazole was administered twice daily from Days -5 to -1 or Days 5 to 9 (depending on assigned treatment period), 1 hour before breakfast and dinner, and from Days 1 to 4 or Days 10 to 13, 1 hour prior to the administration of AZD1722 |
Inclusion Criteria: 1. Healthy male and female volunteers aged 18 to 65 years 2. Females of childbearing potential had to have a negative pregnancy test and females of childbearing potential included in the study had to use 2 effective methods of avoiding pregnancy, females of nonchildbearing poten...
AZD1722 salt is an investigational small molecule being studied in a food interaction study in healthy volunteers. The completed Phase 1 trial assessed the effects of food on the drug when given as a tablet. It is not approved for any indication and remains in clinical development.
AZD1722 salt is being developed by Ardelyx, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ARDX. The company conducted a Phase 1 food interaction study with the drug in healthy volunteers in the United States.
AZD1722 salt is in Phase 1 clinical development. A single Phase 1 trial, NCT02226783, has been completed. The drug is investigational and has not been approved by regulatory authorities.
AZD1722 salt has one completed Phase 1 clinical trial, NCT02226783, titled "D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects." The study enrolled 37 participants in the United States and was a controlled, randomized, open-label trial.
The mechanism of action of AZD1722 salt is not disclosed in the available clinical trial information. The completed Phase 1 study focused on food interaction and pharmacokinetics in healthy volunteers rather than therapeutic efficacy.