Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects

Study identifier:D9480C00012

ClinicalTrials.gov identifier:NCT04788641

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Two-Cohort, Randomised Sequence, Cross-over, Open-label Study to Assess the Effect of a Single Dose of Sodium Zirconium Cyclosilicate (SZC) on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects

Medical condition

Hyperkalaemia

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Tacrolimus, Cyclosporin, Sodium Zirconium Cyclosilicate, Sodium Zirconium Cyclosilicate

Sex

All

Actual enrollment

62

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 30 Mar 2021
Primary Completion Date: 16 Sept 2021
Study Completion Date: 16 Sept 2021

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2022 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Parexel International

Inclusion and exclusion criteria