Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000515-68 | EudraCT Number |
Not provided
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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.
The study will comprise:
A screening period of maximum 28 days;
Two treatment periods:
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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) | Effect of co-administered SZC on the Cmax of tacrolimus and cyclosporin in healthy participants was determined. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Not provided
Inclusion Criteria:
• Healthy male and female subjects aged 18 to 50 years (both inclusive)
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Koernicke, Dr | Parexel Early Phase Clinical Unit Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | 14050 | Germany |
Not provided
| Label | URL |
|---|---|
| Protocol | View source |
| CSR Synopsis | View source |
Not provided
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.
Not provided
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Participants who met all the inclusion and none of the exclusion criteria were randomized at single center. The screening period was from Day -28 to Day -2. All participants signed and dated the Informed consent form before any study procedures were performed. All the study assessments were performed as per the schedule of assessment.
The study was conducted at a single study centre (Berlin, Germany) between 30 March 2021 to 16 September 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (Tacrolimus): Treatment A, Then Treatment B | Participants received a single dose of oral capsules of Tacrolimus on 2 occasions once alone (Treatment A: Tacrolimus) in Treatment Period 1 on Day 1 and once in combination with oral suspension of SZC (Treatment B: Tacrolimus+ SZC) in Treatment Period 2 on Day 1 separated by at least 14 days. Participants had a follow-up period of 7 to 10 days. |
| FG001 | Cohort 1 (Tacrolimus): Treatment B, Then Treatment A | Participants received a single dose of oral capsules of Tacrolimus on 2 occasions once in combination with oral suspension of SZC (Treatment B: Tacrolimus + SZC) in Treatment Period 2 on Day 1 and once alone (Treatment A: Tacrolimus) in Treatment Period 1 on Day 1 and separated by at least 14 days. Participants had a follow-up period of 7 to 10 days. |
| FG002 | Cohort 2 (Cyclosporin): Treatment C, Then Treatment D | Participants received a single dose of oral capsules of Cyclosporin on 2 occasions once alone (Treatment C: Cyclosporin) in Treatment Period 1 on Day 1 and once in combination with oral suspension of SZC (Treatment D: Cyclosporin + SZC) in Treatment Period 2 on Day 1 separated by at least 14 days. Participants had a follow-up period of 7 to 10 days. |
| FG003 | Cohort 2 (Cyclosporin): Treatment D, Then Treatment C | Participants received a single dose of oral capsules of Cyclosporin on 2 occasions once in combination with oral suspension of SZC (Treatment D: Cyclosporin + SZC) in Treatment Period 2 on Day 1 and once alone (Treatment C: Cyclosporin) in Treatment Period 1 on Day 1 and separated by at least 14 days. Participants had a follow-up period of 7 to 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (4 Days) |
| |||||||||||||
| Washout Period (14 Days) |
| |||||||||||||
| Treatment Period 2 (4 Days) |
|
The randomised set consisted of all participants randomised into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (Tacrolimus): Treatment A, Then Treatment B | Participants received a single dose of oral capsules of Tacrolimus on 2 occasions once alone (Treatment A: Tacrolimus) in Treatment Period 1 on Day 1 and once in combination with oral suspension of SZC (Treatment B: Tacrolimus+ SZC) in Treatment Period 2 on Day 1 separated by at least 14 days. Participants had a follow-up period of 7 to 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The randomised set consisted of all participants randomised into the study. Here, the separate rows were created to capture the total Mean(SD) data for each cohort. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) | Effect of co-administered SZC on the Cmax of tacrolimus and cyclosporin in healthy participants was determined. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picogram/milliliter (pg/ml) | 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 |
|
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]
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: Tacrolimus (5 mg) | Participants received a single dose of oral capsules of Tacrolimus. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2020 | Sep 23, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D016572 | Cyclosporine |
| C000597310 | sodium zirconium cyclosilicate |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. | 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. | 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. | 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] |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Cohort 1 (Tacrolimus): Treatment B, Then Treatment A | Participants received a single dose of oral capsules of Tacrolimus on 2 occasions once in combination with oral suspension of SZC (Treatment B: Tacrolimus + SZC) in Treatment Period 2 on Day 1 and once alone (Treatment A: Tacrolimus) in Treatment Period 1 on Day 1 and separated by at least 14 days. Participants had a follow-up period of 7 to 10 days. |
| BG002 | Cohort 2 (Cyclosporin): Treatment C, Then Treatment D | Participants received a single dose of oral capsules of Cyclosporin on 2 occasions once alone (Treatment C: Cyclosporin) in Treatment Period 1 on Day 1 and once in combination with oral suspension of SZC (Treatment D: Cyclosporin + SZC) in Treatment Period 2 on Day 1 separated by at least 14 days. Participants had a follow-up period of 7 to 10 days. |
| BG003 | Cohort 2 (Cyclosporin): Treatment D, Then Treatment C | Participants received a single dose of oral capsules of Cyclosporin on 2 occasions once in combination with oral suspension of SZC (Treatment D: Cyclosporin + SZC) in Treatment Period 2 on Day 1 and once alone (Treatment C: Cyclosporin) in Treatment Period 1 on Day 1 and separated by at least 14 days. Participants had a follow-up period of 7 to 10 days. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 |
| Treatment B: Tacrolimus (5 mg) and SZC (15 g) |
Participants received a single dose of oral capsules of Tacrolimus in combination with oral suspension of SZC. |
| OG002 | Treatment C: Cyclosporin (100 mg) | Participants received a single dose of oral capsules of Cyclosporin. |
| OG003 | Treatment D: Cyclosporin (100 mg) and SZC (15 g) | Participants received a single dose of oral capsules of Cyclosporin in combination with oral suspension of SZC. |
|
|
|
| Primary | 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. | 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. Here, overall number of participants analyzed are the participants with available data that were analyzed for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picogram.hour/milliliter | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picogram.hour/milliliter | 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 | 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. | 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. | Posted | Median | Full Range | hour | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | 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 | 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. | All participants who received at least 1 dose of IMP were included in the safety analysis for the study. | Posted | Count of Participants | Participants | 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] |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 7 |
| 31 |
| EG001 | Treatment B: Tacrolimus (5 mg) and SZC (15 g) | Participants received a single dose of oral capsules of Tacrolimus in combination with oral suspension of SZC. | 0 | 30 | 0 | 30 | 13 | 30 |
| EG002 | Treatment C: Cyclosporin (100 mg) | Participants received a single dose of oral capsules of Cyclosporin. | 0 | 31 | 0 | 31 | 8 | 31 |
| EG003 | Treatment D: Cyclosporin (100 mg) and SZC (15 g) | Participants received a single dose of oral capsules of Cyclosporin in combination with oral suspension of SZC. | 0 | 29 | 0 | 29 | 7 | 29 |
| Rhinitis | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Eyelid pain | Eye disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 24.0 | Non-systematic Assessment |
|
| Nasal injury | Injury, poisoning and procedural complications | MedDRA version 24.0 | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA version 24.0 | Non-systematic Assessment |
|
No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB. Access to this document must be restricted to relevant parties.
| D010456 |
| Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
|
|
| Male |
|
|
|
|
|
|
|
Cyclosporin |
| Geometric LS Mean Ratio (%) |
| 97.23 |
| 2-Sided |
| 90 |
| 92.93 |
| 101.7 |
Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects. |
| Other |
Cyclosporin |
| Geometric LS Mean Ratio (%) |
| 97.04 |
| 2-Sided |
| 90 |
| 92.70 |
| 101.6 |
Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects. |
| Other |
Cyclosporin |
| Geometric LS Mean Ratio (%) |
| 97.55 |
| 2-Sided |
| 90 |
| 87.16 |
| 109.2 |
Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects. |
| Other |
Cyclosporin |
| Geometric LS Mean Ratio (%) |
| 94.12 |
| 2-Sided |
| 90 |
| 85.74 |
| 103.3 |
Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects. |
| Other |
| Any AE with outcome = death |
|
| Any SAE (including events with outcome = death) |
|
| Any AE leading to discontinuation of IMP |
|
| Any AE leading to withdrawal from study |
|