HyperkalaemiaPhase 1NCT04788641

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

A Phase 1 study testing Tacrolimus, Cyclosporin and Sodium Zirconium Cyclosilicate in people with Hyperkalaemia, run by AstraZeneca at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Hyperkalaemia
What is being tested?: Tacrolimus, Cyclosporin and Sodium Zirconium Cyclosilicate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteGermany
Study dates: 30 Mar 2021to 16 Sep 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects aged 18 to 50 years (both inclusive)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Research Site
Berlin, 14050

Other trials in Germany

About this study

Official title: A Two-Cohort, Randomised Sequence, Cross-over, Open-label Study to Assess the Effect of a Single Dose of Sodium Zirconium Cyclosilicate (SZC) on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects

Read the detailed description

The study will comprise:

A screening period of maximum 28 days;
Two treatment periods:
Treatment Period 1 starts with admission to the Clinical Unit on Day -1, followed by dosing on Day 1 with the assigned treatment (A, B, C, or D) as per assigned cohort and treatment sequence, followed by a washout period of at least 14 days.
Treatment Period 2 starts with admission to Clinical Unit on Day -1, followed by dosing on Day 1 with cross-over treatment as per assigned cohort, followed by a follow-up period of 7 to 10 days.
A follow-up visit/early termination visit at 7 to 10 days after the last investigation medicinal product (IMP) administration.

Subjects will be assigned to either Cohort 1 (tacrolimus) or to Cohort 2 (cyclosporin). Each cohort will have 2 treatment periods. Subjects in each cohort will be randomly assigned to one of 2 treatment sequences (AB|BA or CD|DC) where,

Treatment A: Tacrolimus
Treatment B: Tacrolimus + SZC
Treatment C: Cyclosporin
Treatment D: Cyclosporin + SZC

Conditions: Hyperkalaemia
Being tested: Tacrolimus, Cyclosporin, Sodium Zirconium Cyclosilicate
Keywords: Pharmacokinetics, Sodium Zirconium Cyclosilicate, Tacrolimus, Cyclosporin, Drug-drug interaction study
Medical subject headings: Hyperkalemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TacrolimusDrug
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.
CyclosporinDrug
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 CyclosilicateDrug
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.

Study groups in NCT04788641
Study group	Role	What they receive
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. Receives: Drug: Tacrolimus; Drug: Sodium Zirconium Cyclosilicate
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. Receives: Drug: Cyclosporin; Drug: Sodium Zirconium Cyclosilicate

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Concentration (Cmax)
Effect of co-administered SZC on the Cmax of tacrolimus and cyclosporin in healthy participants was determined.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin
Area Under Concentration-time Curve From Time Zero to Infinity (AUCinf)
Effect of co-administered SZC on the AUCinf of tacrolimus and cyclosporin in healthy participants was determined.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin

Secondary outcomes (4)

Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Effect of co-administered SZC on the AUClast of tacrolimus and cyclosporin in healthy participants was determined.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin
Time to Reach Maximum Observed Concentration Following Drug Administration (Tmax)
Effect of co-administered SZC on the tmax of tacrolimus and cyclosporin in healthy participants was determined.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz)
Effect of co-administered SZC on the t½λz of tacrolimus and cyclosporin in healthy participants was determined.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin
Number of Participants With Adverse Events (AEs) and Serious AEs
Safety and tolerability of co-administration of SZC and tacrolimus/cyclosporin as compared to tacrolimus/cyclosporin alone was assessed.
Measured: From the time of IMP administration (Day 1) to Follow-up/Early Termination Visit (7-10 days after last IMP administration) [up to 4 weeks]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 202116 Sep 2021

First posted9 Mar 2021
Study start30 Mar 2021
Primary completion16 Sep 2021
Study completion16 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyperkalaemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04788641
Sponsor's protocol ID: D9480C00012
Other IDs: 2020-000515-68
Status last verified: Apr 2024
First submitted: 5 Mar 2021
Last updated: 5 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Chronic Kidney Disease
Enrolling by invitationPhase 4
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Recruiting
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All Hyperkalaemia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-Cohort, Randomised Sequence, Cross-over, Open-label Study to Assess the Effect of a Single Dose of Sodium Zirconium Cyclosilicate (SZC) on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
ClinicalTrials.gov ID: NCT04788641
Acronym / sponsor ID: D9480C00012
Conditions: Hyperkalaemia
Keywords: Pharmacokinetics, Sodium Zirconium Cyclosilicate, Tacrolimus, Cyclosporin, Drug-drug interaction study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 30 Mar 2021 (actual)
Primary completion: 16 Sep 2021 (actual)
Study completion: 16 Sep 2021 (actual)
First posted: 9 Mar 2021 (actual)
Results: Posted 5 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will comprise:

A screening period of maximum 28 days;
Two treatment periods:
Treatment Period 1 starts with admission to the Clinical Unit on Day -1, followed by dosing on Day 1 with the assigned treatment (A, B, C, or D) as per assigned cohort and treatment sequence, followed by a washout period of at least 14 days.
Treatment Period 2 starts with admission to Clinical Unit on Day -1, followed by dosing on Day 1 with cross-over treatment as per assigned cohort, followed by a follow-up period of 7 to 10 days.
A follow-up visit/early termination visit at 7 to 10 days after the last investigation medicinal product (IMP) administration.

Treatment A: Tacrolimus
Treatment B: Tacrolimus + SZC
Treatment C: Cyclosporin
Treatment D: Cyclosporin + SZC

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1	Experimental	Drug: Tacrolimus, Drug: Sodium Zirconium CyclosilicateSubjects 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	Drug: Cyclosporin, Drug: Sodium Zirconium CyclosilicateSubjects 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy male and female subjects aged 18 to 50 years (both inclusive)

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TacrolimusEach 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	Cohort 1
CyclosporinEach 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	Cohort 2
Sodium Zirconium CyclosilicateEach 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.	Drug	Cohort 1, Cohort 2

Primary outcome

Maximum Observed Concentration (Cmax)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin
Effect of co-administered SZC on the Cmax of tacrolimus and cyclosporin in healthy participants was determined.
Area Under Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin
Effect of co-administered SZC on the AUCinf of tacrolimus and cyclosporin in healthy participants was determined.

4 secondary outcomes

Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin
Time to Reach Maximum Observed Concentration Following Drug Administration (Tmax)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin
Number of Participants With Adverse Events (AEs) and Serious AEs
Time frame: From the time of IMP administration (Day 1) to Follow-up/Early Termination Visit (7-10 days after last IMP administration) [up to 4 weeks]

Results and safety

Results posted to the registry on 5 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (Tacrolimus): Treatment A, Then Treatment B	16	16
Cohort 1 (Tacrolimus): Treatment B, Then Treatment A	15	15
Cohort 2 (Cyclosporin): Treatment C, Then Treatment D	16	16
Cohort 2 (Cyclosporin): Treatment D, Then Treatment C	15	15

Primary outcome: Maximum Observed Concentration (Cmax)

Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin. Geometric mean (Geometric Coefficient of Variation). Unit: Picogram/milliliter (pg/ml)

Measure	Treatment A: Tacrolimus (5 mg) n = 31	Treatment B: Tacrolimus (5 mg) and SZC (15 g) n = 30	Treatment C: Cyclosporin (100 mg) n = 31	Treatment D: Cyclosporin (100 mg) and SZC (15 g) n = 29
Value	27140 (37.61)	19350 (35.88)	593.6 (19.54)	608.1 (25.28)

Treatment A: Tacrolimus (5 mg) vs Treatment B: Tacrolimus (5 mg) and SZC (15 g): Geometric LS Mean Ratio (%): 71.10 (90% CI 65.44 to 77.24)
Treatment C: Cyclosporin (100 mg) vs Treatment D: Cyclosporin (100 mg) and SZC (15 g): Geometric LS Mean Ratio (%): 102.9 (90% CI 96.11 to 110.1)

Population analysed: The PK analysis set consisted of all participants in the safety analysis set and who had at least 1 quantifiable whole blood concentration post-dose for tacrolimus (Cohort 1) or for cyclosporin (Cohort 2) and who had no major protocol deviations thought to impact on the analysis of the PK data.

Primary outcome: Area Under Concentration-time Curve From Time Zero to Infinity (AUCinf)

Measure	Treatment A: Tacrolimus (5 mg) n = 26	Treatment B: Tacrolimus (5 mg) and SZC (15 g) n = 27	Treatment C: Cyclosporin (100 mg) n = 31	Treatment D: Cyclosporin (100 mg) and SZC (15 g) n = 29
Value	267900 (50.20)	171700 (48.95)	1884 (25.90)	1810 (23.91)

Treatment A: Tacrolimus (5 mg) vs Treatment B: Tacrolimus (5 mg) and SZC (15 g): Geometric LS Mean Ratio (%): 62.91 (90% CI 55.64 to 71.13)
Treatment C: Cyclosporin (100 mg) vs Treatment D: Cyclosporin (100 mg) and SZC (15 g): Geometric LS Mean Ratio (%): 97.23 (90% CI 92.93 to 101.7)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of IMP administration (Day 1) to Follow-up/Early Termination Visit (7-10 days after last IMP administration) [up to 4 weeks]. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: Tacrolimus (5 mg)	0 of 31 (0%)	7 of 31 (22.6%)	0 of 31
Treatment B: Tacrolimus (5 mg) and SZC (15 g)	0 of 30 (0%)	13 of 30 (43.3%)	0 of 30
Treatment C: Cyclosporin (100 mg)	0 of 31 (0%)	8 of 31 (25.8%)	0 of 31
Treatment D: Cyclosporin (100 mg) and SZC (15 g)	0 of 29 (0%)	7 of 29 (24.1%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
ProtocolLink provided by the sponsor.
CSR SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Koernicke, Dr principal investigator

Parexel Early Phase Clinical Unit Berlin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tacrolimus, Cyclosporin and Sodium Zirconium Cyclosilicate in people with Hyperkalaemia, run by AstraZeneca at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Concentration (Cmax) (time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose of tacrolimus or cyclosporin). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04788641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.