Phase 1
Completed N=62
Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
Hyperkalaemia
Source: ClinicalTrials.gov NCT04788641 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Maximum Observed Concentration (Cmax) — 27140; 19350; 593.6; 608.1 Picogram/milliliter (pg/ml)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Concentration (Cmax) |
27140; 19350; 593.6; 608.1 | — |
| PRIMARY Area Under Concentration-time Curve From Time Zero to Infinity (AUCinf) |
267900; 171700; 1884; 1810 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) |
240800; 159000; 1792; 1718 | — |
| SECONDARY Time to Reach Maximum Observed Concentration Following Drug Administration (Tmax) |
1.75; 1.50; 1.50; 1.25 | — |
| SECONDARY Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) |
33.59; 33.31; 9.223; 8.647 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious AEs |
7; 13; 8; 7; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and female subjects aged 18 to 50 years (both inclusive)
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04788641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.