Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04788641 | Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects | PHASE1 | COMPLETED | 62 | — | — | Mar 30, 2021 | Sep 16, 2021 | Apr 5, 2024 | 1 | Germany |
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...