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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ardelyx
• Collaborator: AstraZeneca

Criteria

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.