Clinical trial NCT02226783: D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers Food Interaction Study
Keywords: Phase I
Healthy subjects
PK
PD
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
First posted: 2014-08-27
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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)

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Stool samples will be collected over 24 hr periods from day -2 to Day 17
Secondary outcomes:
measure: 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
timeFrame: Stool samples will be collected over 24 hr periods from day -2 to Day 17
measure: 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
timeFrame: Urine will be collected in 24 hour intervals from Day -2 to Day 17
measure: Pharmacokinetic: To evaluate the plasma concentrations of AZD1722
timeFrame: 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
Other outcomes:
measure: Safety:- To evaluate the safety of AZD1722
timeFrame: Safety assessments will be performed throughout the study from Baseline to final follow-up visit (Day-2 to Day 26)
measure: 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
timeFrame: Stool and urine samples will be collected over 24 hr periods from day -2 to Day 14
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles Phase I Services, LLC
name: David Mathews, MD
role: PRINCIPAL_INVESTIGATOR
References: