Healthy Volunteers Food Interaction Study
Conditions
Keywords
Phase I, Healthy subjects, PK, PD
Brief 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
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)
Interventions
DRUGAZD1722 salt tablet
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).
DRUGAZD1722 free base tablet
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).
DRUGAZD1722 free base tablet + Omeprazole
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
Sponsors
Ardelyx
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 potential to fulfill 1 of the following criteria: 1. 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 2. Documentation of irreversible surgical sterilization by hysterectomy, tubal occlusion, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation 3. 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 4. Regular bowel habits of at least 1 stool portion per day.
Exclusion criteria
(1) 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. (5) 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. (7) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Stool consistency, weight, and frequency measured on a daily basis |
| 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 | Urinary sodium and phosphorus content over 24-hour intervals |
| 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 | AZD1722 plasma concentrations |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety:- To evaluate the safety of AZD1722 | Safety assessments will be performed throughout the study from Baseline to final follow-up visit (Day-2 to Day 26) | Adverse events, vital signs, physical examinations, ECGs, and laboratory assessments (chemistry, hematology, and urinalysis) |
| Exploratory:-To evaluate the effect of high and low gastric pH on the PD of AZD1722 following twice daily administration of an AZD1722 free-base tablet formulation given with and without omeprazole | Stool and urine samples will be collected over 24 hr periods from day -2 to Day 14 | Stool sodium and phosphorus content; stool frequency, weight, and consistency; and urine sodium and phosphorus content assessed over 24-hour intervals |
Countries
United States
Outcome results
None listed