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

Ardelyx

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Omeprazole; Drug: AZD1722

Study type: Interventional

Funder types: Industry

Identifiers

NCT02249936

D5611C00002

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 3 patient groups

AZD1722 HCl Capsule

Experimental group

Description:

15 mg bid AZD1722 HCl and 20 mg bid Omeprazole

Treatment:

Drug: AZD1722

Drug: Omeprazole

AZD1722 HCl Tablet

Experimental group

Description:

15 mg bid AZD1722 HCl and 20 mg bid Omeprazole

Treatment:

Drug: AZD1722

Drug: Omeprazole

AZD1722 Free-base Tablet

Experimental group

Description:

15 mg bid AZD1722 and 20 mg bid Omeprazole

Treatment:

Drug: AZD1722

Drug: Omeprazole