Clinical trial NCT03283267: A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Official title: A Single-center Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperkalemia
Keywords: Healthy Chinese Subjects, Pharmacodynamic Study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-09-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline to ZS treatment period in urine potassium excretion.
timeFrame: Study Day 3 and 4 vs Study Day 7 and 8.
Secondary outcomes:
measure: Mean change from baseline to ZS treatment period in urine sodium excretion.
timeFrame: Study Day 3 and 4 vs Study Day 7 and 8.
measure: Mean change from baseline to ZS treatment period in serum potassium (S-K).
timeFrame: Study Day 3 and 4 vs Study Day 7 and 8.
Other outcomes:
measure: Number of subjects with adverse events
timeFrame: From Day 1 through Follow-up visit
measure: Changes in vital signs
timeFrame: Through study completion, up to 10 days
measure: Changes in standard Electrocardiograph (ECG ) parameters
timeFrame: Through study completion, up to 10 days
measure: Changes in standard physical examination parameters including height
timeFrame: Through study completion, up to 10 days
measure: Changes in standard clinical chemistry lab parameters
timeFrame: Through study completion, up to 10 days
measure: Changes in standard hematology lab parameters
timeFrame: Through study completion, up to 10 days
measure: Changes in Serum calcium (S-Ca)
timeFrame: Through study completion, up to 10 days
measure: Changes in Serum magnesium (S-Mg)
timeFrame: Through study completion, up to 10 days
measure: Changes in Serum sodium (S-Na)
timeFrame: Through study completion, up to 10 days
measure: Changes in Serum phosphate (S-PO4)
timeFrame: Through study completion, up to 10 days
measure: Changes in Serum bicarbonate (S-HCO3)
timeFrame: Through study completion, up to 10 days
measure: Changes in Blood urea nitrogen (BUN)
timeFrame: Through study completion, up to 10 days
measure: Number of subjects with Serious adverse events
timeFrame: Through study completion and follow-up visit, up to 34 Days
Locations:
city: Hong Kong
country: Hong Kong
facility: Research Site
Study officials:
References: