A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)

Hyperkalemia Clinical Trial

Official title:

A Single-center Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283267
• Other study ID #: D9483C00001
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2017
• Last updated: December 18, 2017
• Start date: October 24, 2017
• Est. completion date: November 23, 2017

Study information

• Verified date: December 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 potassium and sodium excretion in healthy Chinese subjects on a standardized, low sodium and high potassium diet.

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 g (1:1) once daily (qd) in conjunction with breakfast and will be continued with a standard diet during the ZS treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 23, 2017
• Est. primary completion date: November 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures

2. Female and/or male healthy Chinese subjects aged between 18 and 55 inclusive who reside in Hong Kong

3. Ability to have repeated blood draws or effective venous catheterization

4. 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 Criteria:

1. Participation in another clinical study with an investigational product during the last 3 months

2. 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.

3. 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

4. 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.

5. Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening.

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

Drug:
• Sodium Zirconium Cyclosilicate (ZS)
Sodium zirconium cyclosilicate (ZS) is a non-absorbed, inorganic crystalline compound that selectively captures potassium ions in exchange for sodium and hydrogen ions in the gastrointestinal tract after oral administration.

Locations

Country	Name	City	State
Hong Kong	Research Site	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects with adverse events		From Day 1 through Follow-up visit
Other	Changes in vital signs		Through study completion, up to 10 days
Other	Changes in standard Electrocardiograph (ECG ) parameters		Through study completion, up to 10 days
Other	Changes in standard physical examination parameters including height		Through study completion, up to 10 days
Other	Changes in standard clinical chemistry lab parameters		Through study completion, up to 10 days
Other	Changes in standard hematology lab parameters		Through study completion, up to 10 days
Other	Changes in Serum calcium (S-Ca)		Through study completion, up to 10 days
Other	Changes in Serum magnesium (S-Mg)		Through study completion, up to 10 days
Other	Changes in Serum sodium (S-Na)		Through study completion, up to 10 days
Other	Changes in Serum phosphate (S-PO4)		Through study completion, up to 10 days
Other	Changes in Serum bicarbonate (S-HCO3)		Through study completion, up to 10 days
Other	Changes in Blood urea nitrogen (BUN)		Through study completion, up to 10 days
Other	Number of subjects with Serious adverse events		Through study completion and follow-up visit, up to 34 Days
Primary	Mean change from baseline to ZS treatment period in urine potassium excretion.	The 48- hour urine potassium excretion on Study Days 3 and 4 (baseline) will be compared with 48-hour urine potassium excretion on Study Days 7 and 8 (on study drug).	Study Day 3 and 4 vs Study Day 7 and 8.
Secondary	Mean change from baseline to ZS treatment period in urine sodium excretion.	The 48- hour urine sodium excretion on Study Days 3 and 4 (baseline) will be compared with 48- hour urine sodium excretion on Study Days 7 and 8 (on study drug).	Study Day 3 and 4 vs Study Day 7 and 8.
Secondary	Mean change from baseline to ZS treatment period in serum potassium (S-K).	Mean change in S-K from the Baseline Period (Day 3 and 4) to the ZS Treatment Period (Day 7 and 8).	Study Day 3 and 4 vs Study Day 7 and 8.