Healthy Volunteers Food Interaction StudyPhase 1NCT02226783
D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects
A Phase 1 study testing AZD1722 salt tablet, AZD1722 free base tablet and AZD1722 free base tablet + Omeprazole in people with Healthy Volunteers Food Interaction Study, run by Ardelyx at 1 site in United States.
Trial summary
Study to evaluate the effect of intake of food in comparison to fasting condition on pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet formulation Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Food Interaction Study
- What is being tested?
- AZD1722 salt tablet, AZD1722 free base tablet and AZD1722 free base tablet + Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female volunteers aged 18 to 65 years
- 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 potential to fulfill 1 of the following criteria:
- Postmenopausal, defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatment and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range
- Documentation of irreversible surgical sterilization by hysterectomy, tubal occlusion, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
- Had a body mass index (BMI) of 18 and 30 kg/m2, inclusive, and weight at least 50 kg and no more than 100 kg
- Regular bowel habits of at least 1 stool portion per day.
Who cannot join
- History of clinically-significant disease or disorder (2) History or presence of GI, hepatic, or renal disease, including GI surgery, or any condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. (3) Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks (4) any clinically-significant abnormalities in clinical chemistry, hematology, or urinalysis.
- Abnormal vital signs after a 10-minute supine rest, any clinically-significant abnormalities in rhythm, conduction, or morphology of resting ECG (6) Prolonged QTcF greater than 450 ms or shortened QTcF less than 340 ms or family history of long QT syndrome.
- Loose stools (Bristol Stool Form Score [BSFS] of 6 or 7) 2 or more days during the 7 days prior to randomization (8) Use of medications that are known to affect stool consistency and/or GI motility, including fiber supplements, probiotic supplements, probiotic supplements in medication form, antidiarrheals, prokinetic drugs, enemas, probiotic medications or supplements (ie, Activia®); or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study in Healthy Subjects to Evaluate the Pharmacodynamics (PD) of AZD1722 Given With and Without Food (Part A) and a 2-way Crossover to Evaluate the PD of AZD1722 Given as a Free-base Tablet With and Without Omeprazole (Part B)
Study to evaluate the effect of intake of food in comparison to fasting condition on pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet formulation
Read the detailed description
A Phase I, Open-label, Randomized, Single-center, 3-way Crossover Study in Healthy Subjects to Evaluate the Pharmacodynamics Effects of AZD1722 Administered With and Without Food (Part A) plus a 2-way Crossover in Subjects to Evaluate the Pharmacodynamic Effect of AZD1722 Administered as an AZD1722 Free-base Tablet with and without Omeprazole (Part B)
- Being tested
- AZD1722 salt tablet, AZD1722 free base tablet, AZD1722 free base tablet + Omeprazole
- Keywords
- Phase I, Healthy subjects, PK, PD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1722 salt tabletDrug
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 tabletDrug
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 + OmeprazoleDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: AZD1722 salt tablet |
| 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 Receives: Drug: AZD1722 salt tablet |
| 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 Receives: Drug: AZD1722 salt tablet |
| 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 Receives: Drug: AZD1722 free base tablet |
| 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 Receives: Drug: AZD1722 free base tablet; Drug: AZD1722 free base tablet + Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Sodium and phosphorus content in stool collected over 24-hour intervals
Measured: Stool samples will be collected over 24 hr periods from day -2 to Day 17
Secondary outcomes (3)
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 consistency, weight, and frequency measured on a daily basis
Measured: 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
Urinary sodium and phosphorus content over 24-hour intervals
Measured: Urine will be collected in 24 hour intervals from Day -2 to Day 17
Pharmacokinetic: To evaluate the plasma concentrations of AZD1722
AZD1722 plasma concentrations
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers Food Interaction StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Mathews, MD, Principal investigator, Quintiles Phase I Services, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226783
- Sponsor's protocol ID
- D5611C00003
- Status last verified
- Sep 2015
- First submitted
- 26 Aug 2014
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study in Healthy Subjects to Evaluate the Pharmacodynamics (PD) of AZD1722 Given With and Without Food (Part A) and a 2-way Crossover to Evaluate the PD of AZD1722 Given as a Free-base Tablet With and Without Omeprazole (Part B)
- ClinicalTrials.gov ID
- NCT02226783
- Acronym / sponsor ID
- D5611C00003
- Keywords
- Phase I, Healthy subjects, PK, PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the effect of intake of food in comparison to fasting condition on pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet formulation
Detailed description
A Phase I, Open-label, Randomized, Single-center, 3-way Crossover Study in Healthy Subjects to Evaluate the Pharmacodynamics Effects of AZD1722 Administered With and Without Food (Part A) plus a 2-way Crossover in Subjects to Evaluate the Pharmacodynamic Effect of AZD1722 Administered as an AZD1722 Free-base Tablet with and without Omeprazole (Part B)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A AZD1722 salt tablet (fasted) | Experimental | Drug: AZD1722 salt tabletPart 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 | Drug: AZD1722 salt tabletPart 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 | Drug: AZD1722 salt tabletPart 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 | Drug: AZD1722 free base tabletPart 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 | Drug: AZD1722 free base tablet, Drug: AZD1722 free base tablet + OmeprazolePart 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male and female volunteers aged 18 to 65 years
- 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 potential to fulfill 1 of the following criteria:
- Had a body mass index (BMI) of 18 and 30 kg/m2, inclusive, and weight at least 50 kg and no more than 100 kg
- Regular bowel habits of at least 1 stool portion per day.
Key exclusion criteria (3 listed)
- History of clinically-significant disease or disorder (2) History or presence of GI, hepatic, or renal disease, including GI surgery, or any condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. (3) Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks (4) any clinically-significant abnormalities in clinical chemistry, hematology, or urinalysis.
- Abnormal vital signs after a 10-minute supine rest, any clinically-significant abnormalities in rhythm, conduction, or morphology of resting ECG (6) Prolonged QTcF greater than 450 ms or shortened QTcF less than 340 ms or family history of long QT syndrome.
- Loose stools (Bristol Stool Form Score [BSFS] of 6 or 7) 2 or more days during the 7 days prior to randomization (8) Use of medications that are known to affect stool consistency and/or GI motility, including fiber supplements, probiotic supplements, probiotic supplements in medication form, antidiarrheals, prokinetic drugs, enemas, probiotic medications or supplements (ie, Activia®); or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD1722 salt tabletAZD1722 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). | Drug | Treatment A AZD1722 salt tablet (fasted), Treatment B AZD1722 salt tablet (fed), Treatment C AZD1722 salt tablet (fasted) |
| AZD1722 free base tabletAZD1722 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). | Drug | Treat D AZD1722 free-base tablet (fast), Treat E AZD1722 free-base+Omeprazole |
| AZD1722 free base tablet + OmeprazoleAZD1722 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 | Drug | Treat E AZD1722 free-base+Omeprazole |
Primary outcome
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
Time frame: 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
3 secondary outcomes
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
Time frame: 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
Time frame: Urine will be collected in 24 hour intervals from Day -2 to Day 17
Pharmacokinetic: To evaluate the plasma concentrations of AZD1722
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Mathews, MD principal investigator
Quintiles Phase I Services, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD1722 salt tablet, AZD1722 free base tablet and AZD1722 free base tablet + Omeprazole in people with Healthy Volunteers Food Interaction Study, run by Ardelyx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Stool samples will be collected over 24 hr periods from day -2 to Day 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.