Status:
COMPLETED
Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Hyperkalaemia
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- • Healthy male and female subjects aged 18 to 50 years (both inclusive)
Exclusion
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important abnormalities in rhythm, conduction or morphology of the 12-lead safety electrocardiogram (ECG), at screening visit and/or admission to the Clinical Unit.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to SZC, tacrolimus, or cyclosporin.
- Subjects who have previously received SZC.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04788641
Start Date
March 30 2021
End Date
September 16 2021
Last Update
April 5 2024
Active Locations (1)
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1
Research Site
Berlin, Germany, 14050