A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD1722; Drug: Omeprazole

• Registration Number: NCT02249936
• Lead Sponsor: Ardelyx

Brief Summary

The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of different formulations of AZD1722 in healthy male and female subjects taking Omeprazole.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-09
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-25
• Last Update Submitted: 2014-09-25
• Study First Posted: 2014-09-26
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Healthy man or woman
• Body mass index between 18 and 29.9 kg/m2

Exclusion Criteria

• Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract
• Any surgery on the small intestine or colon, excluding appendectomy or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AZD1722 Free-base Tablet	AZD1722	15 mg bid AZD1722 and 20 mg bid Omeprazole
AZD1722 HCl Tablet	Omeprazole	15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
AZD1722 HCl Tablet	AZD1722	15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
AZD1722 HCl Capsule	AZD1722	15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
AZD1722 Free-base Tablet	Omeprazole	15 mg bid AZD1722 and 20 mg bid Omeprazole
AZD1722 HCl Capsule	Omeprazole	15 mg bid AZD1722 HCl and 20 mg bid Omeprazole

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	8 days	Measurement of safety laboratories, ECGs, vitals signs and physical exams

Secondary Outcome Measures

Name	Time	Method
Sodium levels in stool and urine	8 days	Pharmacodynamic activity
Plasma drug concentration to calculate AUC	8 days	Pharmacokinetics

Trial Locations

Locations (1)

ICON Development Solutions; 🇺🇸 Omaha, Nebraska, United States