Approval Probability
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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 a small molecule being investigated for hyperkalaemia, a condition of elevated potassium levels in the blood. It is currently in Phase 1 clinical development. The drug is being studied in a controlled trial to assess its effects, though it remains investigational and is not yet approved for this use.
The specific molecular target of Cyclosporin is not disclosed in the available information. The drug is being studied for its potential role in managing hyperkalaemia, but its mechanism of action has not been specified in the clinical trial data provided.
Cyclosporin is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research on this drug for the treatment of hyperkalaemia.
Cyclosporin is in Phase 1 clinical development for hyperkalaemia. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
Cyclosporin has been studied in one completed Phase 1 clinical trial with the identifier NCT04788641. This trial assessed the effect of sodium zirconium cyclosilicate on the pharmacokinetics of tacrolimus and cyclosporin in healthy subjects. The study enrolled 62 participants and was conducted in Germany.
Cyclosporin and cyclosporine are alternative names for the same drug. In the clinical trial data, the drug is referred to as Cyclosporin, and it is being studied for hyperkalaemia. The trial NCT04788641 specifically examines its pharmacokinetics in healthy volunteers.