Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese Subjects

Ardelyx

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: AZD1722

Study type: Interventional

Funder types: Industry

Identifiers

NCT02176252

D5611C00005

Details and patient eligibility

About

The study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days in order to allow for including Japanese subjects in future global studies. A cohort of Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by digital ECGs (dECG) recordings, also in Caucasian subjects.

Enrollment: 83 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, inclusive

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
• 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: N/A

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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83 participants in 1 patient group

AZD1722

Experimental group

Description:

Dose escalation from 5 mg to 90 mg BID

Treatment:

Drug: Placebo

Drug: AZD1722