A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722

Ardelyx

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD1722; Drug: Renvela

Study type: Interventional

Funder types: Industry

Identifiers

NCT02346890

D5611C00006

Details and patient eligibility

About

The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.

Enrollment: 16 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 to the subject.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

AZD1722 alone

Experimental group

Description:

15 mg BID

Treatment:

Drug: AZD1722

AD1722 with Renvela

Experimental group

Description:

AZD1722 15 mg BID and Renvela 800 mg TID

Treatment:

Drug: Renvela

Drug: AZD1722