CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 62 enrolled
Drug / intervention
Tacrolimus +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04788641
NCT04788641Phase 1Completed
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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

AstraZeneca·interventional·Posted Mar 9, 2021·Updated Apr 5, 2024

In Brief

A Phase 1 clinical trial evaluating Tacrolimus, Cyclosporin, and 1 other intervention for Hyperkalaemia. Completed, enrolled 62 participants across 1 site.

Detailed 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 at a single study centre.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperkalaemia
CountriesGermany
CollaboratorsParexel

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedMar 9, 2021
Enrollment StartMar 30, 2021
Primary CompletionSep 16, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.3 years ago

Interventions

Tacrolimusdrug

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.

Cyclosporindrug

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.

Sodium Zirconium Cyclosilicatedrug

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.