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Cyclosporin · 1 trial · 1 indication
Effect of co-administered SZC on the Cmax of tacrolimus and cyclosporin in healthy participants was determined.
Effect of co-administered SZC on the AUCinf of tacrolimus and cyclosporin in healthy participants was determined.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 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. |
| Cohort 2 | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Tacrolimus | DRUG | 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. |
| Cyclosporin | DRUG | 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 Cyclosilicate | DRUG | 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. |
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 inf...
Cyclosporin is being studied in hyperkalaemia, the condition of elevated blood potassium. AstraZeneca PLC is developing it as a small molecule in Phase 1 clinical development. The single recorded trial enrolled healthy volunteers rather than patients with the condition, so the work is early-stage and investigational.
Cyclosporin targets PPIA, also known as peptidyl-prolyl cis-trans isomerase A, and is classified as a modulator of that target. PPIA is the molecular target named for this asset. This target interaction is the basis for the drug's activity in the hyperkalaemia program.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of Cyclosporin for hyperkalaemia. The company is running the clinical program for this small molecule asset in the nephrology therapeutic area.
Cyclosporin is in Phase 1 clinical development for hyperkalaemia. It is investigational and has not been approved for this use. One trial has been completed, and no trials are currently active, so the program remains at an early stage of testing.
Cyclosporin has been studied in trial NCT04788641, titled a study to assess the effect of sodium zirconium cyclosilicate on the pharmacokinetics of tacrolimus and cyclosporin in healthy subjects. The Phase 1 trial was completed in Germany with 62 enrolled healthy volunteers, was randomized, and used a controlled design.
Cyclosporin and ciclosporin refer to the same medicine, with the spelling differing by region. In this hyperkalaemia program, AstraZeneca PLC is developing the small molecule under the Cyclosporin name, and it targets PPIA. It is in Phase 1 development and is investigational for this indication.