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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
This study will be an open-label, randomised sequence, 2-period, 2-cohort, 2-treatment in each cohort, cross-over study in healthy subjects (males and females of non-childbearing potential), performed at a single study centre.
The study will comprise: * A screening period of maximum 28 days; * Two treatment periods: * Treatment Period 1 starts with admission to the Clinical Unit on Day -1, followed by dosing on Day 1 with the assigned treatment (A, B, C, or D) as per assigned cohort and treatment sequence, followed by a washout period of at least 14 days. * Treatment Period 2 starts with admission to Clinical Unit on Day -1, followed by dosing on Day 1 with cross-over treatment as per assigned cohort, followed by a follow-up period of 7 to 10 days. * A follow-up visit/early termination visit at 7 to 10 days after the last investigation medicinal product (IMP) administration. Subjects will be assigned to either Cohort 1 (tacrolimus) or to Cohort 2 (cyclosporin). Each cohort will have 2 treatment periods. Subjects in each cohort will be randomly assigned to one of 2 treatment sequences (AB\|BA or CD\|DC) where, * Treatment A: Tacrolimus * Treatment B: Tacrolimus + SZC * Treatment C: Cyclosporin * Treatment D: Cyclosporin + SZC
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
Yes
Research Site
Berlin, Germany
Start Date
March 30, 2021
Primary Completion Date
September 16, 2021
Completion Date
September 16, 2021
Last Updated
April 5, 2024
62
ACTUAL participants
Tacrolimus
DRUG
Cyclosporin
DRUG
Sodium Zirconium Cyclosilicate
DRUG
Lead Sponsor
AstraZeneca
Collaborators
NCT03813407
NCT04727528
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04997161