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D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02226783
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
Ardelyx

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Food Interaction Study Drug: AZD1722 salt tablet Drug: AZD1722 free base tablet Drug: AZD1722 free base tablet + Omeprazole Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : March 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A AZD1722 salt tablet (fasted)
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
Drug: AZD1722 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).

Experimental: Treatment B AZD1722 salt tablet (fed)
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
Drug: AZD1722 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).

Experimental: Treatment C AZD1722 salt tablet (fasted)
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
Drug: AZD1722 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).

Experimental: Treat D AZD1722 free-base tablet (fast)
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
Drug: AZD1722 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).

Experimental: Treat E AZD1722 free-base+Omeprazole
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
Drug: AZD1722 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).

Drug: AZD1722 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Stool consistency, weight, and frequency measured on a daily basis

  2. 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 ]
    Urinary sodium and phosphorus content over 24-hour intervals

  3. 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 ]
    AZD1722 plasma concentrations


Other Outcome Measures:
  1. Safety:- To evaluate the safety of AZD1722 [ Time Frame: 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)

  2. 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 [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226783


Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States, KS 66211
Sponsors and Collaborators
Ardelyx
Investigators
Principal Investigator: David Mathews, MD Quintiles Phase I Services, LLC

Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT02226783     History of Changes
Other Study ID Numbers: D5611C00003
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by Ardelyx:
Phase I
Healthy subjects
PK
PD

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action