Recent Updates
Recently added Catalysts

AZD1722 salt

Phase 1

Undisclosed | Small molecule | Other |Ardelyx, Inc.|Trials Updated: Sep 22, 2015

AZD1722 salt target and mechanism

ModalitySmall molecule

Also known as AZD1722 salt tablet

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

AZD1722 salt clinical trials

AZD1722 salt · 1 trial · 1 indication

Phase 1 1
NCT02226783D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy SubjectsHealthy Volunteers Food Interaction Study
COMPLETED37 Analytics
PHASE1COMPLETED
D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects
Healthy Volunteers Food Interaction StudyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacodynamic:- To evaluate the effect of intake of food in comparison to fasting condition on PD of AZD1722 following a twice-daily administration of AZD1722 tablet formulation
Stool samples will be collected over 24 hr periods from day -2 to Day 17

Sodium and phosphorus content in stool collected over 24-hour intervals

Secondary Endpoints

Pharmacodynamic:- To evaluate the effect of intake of food in comparison to fasting condition on PD of AZD1722 following twice-daily administration of an AZD1722 tablet formulation
Stool samples will be collected over 24 hr periods from day -2 to Day 17
Pharmacodynamic:- To evaluate the effect of intake of food in comparison to fasting condition on PD ofAZD1722 following twice-daily administration of an AZD1722 tablet formulation
Urine will be collected in 24 hour intervals from Day -2 to Day 17
Pharmacokinetic: To evaluate the plasma concentrations of AZD1722
Predose, 1, 2, and 4 hours post morning dose for measurement of AZD1722 in plasma will be taken on days 1, 4, 7, 10, 13, and 16
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment A AZD1722 salt tablet (fasted)EXPERIMENTALPart 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)EXPERIMENTALPart 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)EXPERIMENTALPart 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)EXPERIMENTALPart 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+OmeprazoleEXPERIMENTALPart 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

Interventions

NameTypeDescription
AZD1722 salt tabletDRUGAZD1722 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 tabletDRUGAZD1722 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 + OmeprazoleDRUGAZD1722 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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about AZD1722 salt

What is AZD1722 salt?

AZD1722 salt is an investigational small molecule developed by Ardelyx, Inc. (ticker ARDX). It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific therapeutic indication for AZD1722 salt has not been disclosed.

Who is developing AZD1722 salt?

AZD1722 salt is being developed by Ardelyx, Inc., which trades on the Nasdaq under the ticker ARDX. Ardelyx is the sponsor of the clinical program for AZD1722 salt.

What phase is AZD1722 salt in?

AZD1722 salt is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.

What clinical trials is AZD1722 salt in?

AZD1722 salt has been evaluated in one completed Phase 1 trial, NCT02226783, titled D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects. The trial enrolled 37 healthy volunteers in the United States and was randomized and controlled.

Is AZD1722 salt the same as AZD1722 salt tablet?

Yes, AZD1722 salt tablet is another name for AZD1722 salt. The completed Phase 1 trial, NCT02226783, used the tablet formulation of AZD1722 salt in healthy subjects.