Study identifier:D9480C00012
ClinicalTrials.gov identifier:NCT04788641
EudraCT identifier:2020-000515-68
CTIS identifier:N/A
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
Hyperkalaemia
Phase 1
Yes
Tacrolimus, Cyclosporin, Sodium Zirconium Cyclosilicate
All
62
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2024 by AstraZeneca
AstraZeneca
Parexel International
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 Subjects in Cohort 1 will be randomised in a 1:1 ratio to receive one of the 2 treatment sequences and then cross-over to the other: tacrolimus alone (treatment A) followed by the combination treatment of tacrolimus and SZC (treatment B) or vice versa. | Drug: Tacrolimus Each subject in this cohort will receive a single dose of oral capsules of tacrolimus on 2 occasions, once alone and once in combination with oral suspension of SZC. Drug administrations will occur after a 12 hour overnight fast. Drug: Sodium Zirconium Cyclosilicate Each subject will receive single oral doses of SZC with tacrolimus (cohort 1) or cyclosporin (cohort 2) under fasted conditions. The doses will be administered after an overnight fast of at least 12 hours. |
Experimental: Cohort 2 Subjects in Cohort 2 will be randomised in a 1:1 ratio to receive one of the 2 treatment sequences and then cross-over to the other: cyclosporin alone (treatment C) followed by the combination treatment of cyclosporin and SZC (treatment D) or vice versa. | Drug: Cyclosporin Each subject will receive a single dose of oral capsules of cyclosporin on 2 occasions, once alone and once in combination with oral suspension of SZC. Drug administrations will occur after a 12 hour overnight fast. Drug: Sodium Zirconium Cyclosilicate Each subject will receive single oral doses of SZC with tacrolimus (cohort 1) or cyclosporin (cohort 2) under fasted conditions. The doses will be administered after an overnight fast of at least 12 hours. |