Status:
COMPLETED
A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Lead Sponsor:
AstraZeneca
Conditions:
Hyperkalemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a single center, inpatient, open label pharmacodynamic study to determine the effect of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for 4 days on pot...
Detailed Description
This study will be conducted at 1 study centre in Hong Kong. Approximately 22 Subjects will be screened to achieve 20 subjects completing the study. Subjects will be randomized to receive ZS 5 g or 10...
Eligibility Criteria
Inclusion
- Key
- Provision of informed consent prior to any study specific procedures
- Female and/or male healthy Chinese subjects aged between 18 and 55 inclusive who reside in Hong Kong
- Ability to have repeated blood draws or effective venous catheterization
- Willing to consume food and beverages using a standardized daily diet containing 40 (± 10%) mEq/day sodium and 128 (± 10%) mEq/day potassium provided by the research site
- Key
Exclusion
- Participation in another clinical study with an investigational product during the last 3 months
- Subjects who were receiving concomitant medications including vitamins, dietary supplements and herbal preparations within 2 weeks prior to Study Day 1 of the Diet Run-in Period.
- Current and/or past history of alcohol abuse within the past year or a positive results (exceed normal range) of breath test for alcohol abuse
- Current and/or past history of drugs abuse within the past year or a positive drug abuse screen, e. g. methylenedioxymethamphetamine, opiate, barbiturates, benzodiazepines, ketamine, cocaine, amphetamine, methamphetamine, marijuana, and methadone.
- Plasma donation within 1 month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening.
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2017
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03283267
Start Date
October 24 2017
End Date
November 23 2017
Last Update
December 19 2017
Active Locations (1)
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1
Research Site
Hong Kong, Hong Kong