Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

March 30, 2021

Primary Completion Date

September 16, 2021

Study Completion Date

September 16, 2021

Conditions
Hyperkalaemia
Interventions
DRUG

Tacrolimus

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.

DRUG

Cyclosporin

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.

DRUG

Sodium Zirconium Cyclosilicate

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.

Trial Locations (1)

14050

Research Site, Berlin

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

AstraZeneca

INDUSTRY