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

NCT03283267 | Completed Phase 1

• 1 other identifier: D9483C00001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkalemia

Keywords

Healthy Chinese Subjects, Pharmacodynamic Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean change from baseline to ZS treatment period in urine sodium excretion.

  Study Day 3 and 4 vs Study Day 7 and 8.

• Mean change from baseline to ZS treatment period in serum potassium (S-K).

  Study Day 3 and 4 vs Study Day 7 and 8.

Other Outcomes (13)

• Number of subjects with adverse events

  From Day 1 through Follow-up visit

• Changes in vital signs

  Through study completion, up to 10 days

• Changes in standard Electrocardiograph (ECG ) parameters

  Through study completion, up to 10 days

Study Arms (2)

ZS 5g, qd

EXPERIMENTAL

Subjects randomized to this arm will receive ZS 5 g qd in conjunction with breakfast during the ZS treatment period and will be continued with a standard diet.

Drug: Sodium Zirconium Cyclosilicate (ZS)

ZS 10g, qd

EXPERIMENTAL

Subjects randomized to this arm will receive ZS 10 g qd in conjunction with breakfast during the ZS treatment period and will be continued with a standard diet.

Drug: Sodium Zirconium Cyclosilicate (ZS)

Interventions

Sodium Zirconium Cyclosilicate (ZS) DRUG

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.

ZS 10g, qd; ZS 5g, qd

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hyperkalemia

Interventions

sodium zirconium cyclosilicate

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 14, 2017
• Study Start: October 24, 2017
• Primary Completion: November 23, 2017
• Study Completion: November 23, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)