Trial Outcomes & Findings for Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects (NCT NCT04788641)
NCT ID: NCT04788641
Last Updated: 2024-04-05
Results Overview
Effect of co-administered SZC on the Cmax of tacrolimus and cyclosporin in healthy participants was determined.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
62 participants
Primary outcome timeframe
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
Results posted on
2024-04-05
Participant Flow
The study was conducted at a single study centre (Berlin, Germany) between 30 March 2021 to 16 September 2021.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Treatment Period 1 (4 Days)
STARTED
|
16
|
15
|
16
|
15
|
|
Treatment Period 1 (4 Days)
COMPLETED
|
16
|
15
|
16
|
15
|
|
Treatment Period 1 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period (14 Days)
STARTED
|
16
|
15
|
16
|
15
|
|
Washout Period (14 Days)
COMPLETED
|
16
|
15
|
16
|
15
|
|
Washout Period (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (4 Days)
STARTED
|
16
|
15
|
16
|
15
|
|
Treatment Period 2 (4 Days)
COMPLETED
|
15
|
15
|
14
|
15
|
|
Treatment Period 2 (4 Days)
NOT COMPLETED
|
1
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Treatment Period 2 (4 Days)
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Treatment Period 2 (4 Days)
Participant decided to discontinue further participation
|
1
|
0
|
0
|
0
|
|
Treatment Period 2 (4 Days)
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Cohort 1 (Tacrolimus): Treatment A, Then Treatment B
n=16 Participants
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.
|
Cohort 1 (Tacrolimus): Treatment B, Then Treatment A
n=15 Participants
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.
|
Cohort 2 (Cyclosporin): Treatment C, Then Treatment D
n=16 Participants
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.
|
Cohort 2 (Cyclosporin): Treatment D, Then Treatment C
n=15 Participants
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.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Cohort 1 (Tacrolimus)
|
38.3 years
STANDARD_DEVIATION 8.9 • n=16 Participants • 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.
|
37.1 years
STANDARD_DEVIATION 9.6 • n=15 Participants • 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.
|
—
|
—
|
37.7 years
STANDARD_DEVIATION 9.1 • n=31 Participants • 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.
|
|
Age, Continuous
Cohort 2 (Cyclosporin)
|
—
|
—
|
33.2 years
STANDARD_DEVIATION 9.0 • n=16 Participants • 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.
|
30.9 years
STANDARD_DEVIATION 8.3 • n=15 Participants • 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.
|
32.1 years
STANDARD_DEVIATION 8.6 • n=31 Participants • 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.
|
|
Age, Customized
18 - 50 years
|
16 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
16 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
62 Participants
n=62 Participants
|
|
Age, Customized
51 years and older
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=62 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=16 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=16 Participants
|
13 Participants
n=15 Participants
|
16 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
59 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
12 Participants
n=16 Participants
|
13 Participants
n=15 Participants
|
54 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=15 Participants
|
3 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
16 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
61 Participants
n=62 Participants
|
PRIMARY outcome
Timeframe: 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 cyclosporinPopulation: 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.
Effect of co-administered SZC on the Cmax of tacrolimus and cyclosporin in healthy participants was determined.
Outcome measures
| Measure |
Treatment A: Tacrolimus (5 mg)
n=31 Participants
Participants received a single dose of oral capsules of Tacrolimus.
|
Treatment B: Tacrolimus (5 mg) and SZC (15 g)
n=30 Participants
Participants received a single dose of oral capsules of Tacrolimus in combination with oral suspension of SZC.
|
Treatment C: Cyclosporin (100 mg)
n=31 Participants
Participants received a single dose of oral capsules of Cyclosporin.
|
Treatment D: Cyclosporin (100 mg) and SZC (15 g)
n=29 Participants
Participants received a single dose of oral capsules of Cyclosporin in combination with oral suspension of SZC.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
27140 Picogram/milliliter (pg/ml)
Geometric Coefficient of Variation 37.61
|
19350 Picogram/milliliter (pg/ml)
Geometric Coefficient of Variation 35.88
|
593.6 Picogram/milliliter (pg/ml)
Geometric Coefficient of Variation 19.54
|
608.1 Picogram/milliliter (pg/ml)
Geometric Coefficient of Variation 25.28
|
PRIMARY outcome
Timeframe: 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 cyclosporinPopulation: 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.
Effect of co-administered SZC on the AUCinf of tacrolimus and cyclosporin in healthy participants was determined.
Outcome measures
| Measure |
Treatment A: Tacrolimus (5 mg)
n=26 Participants
Participants received a single dose of oral capsules of Tacrolimus.
|
Treatment B: Tacrolimus (5 mg) and SZC (15 g)
n=27 Participants
Participants received a single dose of oral capsules of Tacrolimus in combination with oral suspension of SZC.
|
Treatment C: Cyclosporin (100 mg)
n=31 Participants
Participants received a single dose of oral capsules of Cyclosporin.
|
Treatment D: Cyclosporin (100 mg) and SZC (15 g)
n=29 Participants
Participants received a single dose of oral capsules of Cyclosporin in combination with oral suspension of SZC.
|
|---|---|---|---|---|
|
Area Under Concentration-time Curve From Time Zero to Infinity (AUCinf)
|
267900 Picogram.hour/milliliter
Geometric Coefficient of Variation 50.20
|
171700 Picogram.hour/milliliter
Geometric Coefficient of Variation 48.95
|
1884 Picogram.hour/milliliter
Geometric Coefficient of Variation 25.90
|
1810 Picogram.hour/milliliter
Geometric Coefficient of Variation 23.91
|
SECONDARY outcome
Timeframe: 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 cyclosporinPopulation: 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.
Effect of co-administered SZC on the AUClast of tacrolimus and cyclosporin in healthy participants was determined.
Outcome measures
| Measure |
Treatment A: Tacrolimus (5 mg)
n=31 Participants
Participants received a single dose of oral capsules of Tacrolimus.
|
Treatment B: Tacrolimus (5 mg) and SZC (15 g)
n=30 Participants
Participants received a single dose of oral capsules of Tacrolimus in combination with oral suspension of SZC.
|
Treatment C: Cyclosporin (100 mg)
n=31 Participants
Participants received a single dose of oral capsules of Cyclosporin.
|
Treatment D: Cyclosporin (100 mg) and SZC (15 g)
n=29 Participants
Participants received a single dose of oral capsules of Cyclosporin in combination with oral suspension of SZC.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
|
240800 Picogram.hour/milliliter
Geometric Coefficient of Variation 50.79
|
159000 Picogram.hour/milliliter
Geometric Coefficient of Variation 51.13
|
1792 Picogram.hour/milliliter
Geometric Coefficient of Variation 26.46
|
1718 Picogram.hour/milliliter
Geometric Coefficient of Variation 24.39
|
SECONDARY outcome
Timeframe: 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 cyclosporinPopulation: 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.
Effect of co-administered SZC on the tmax of tacrolimus and cyclosporin in healthy participants was determined.
Outcome measures
| Measure |
Treatment A: Tacrolimus (5 mg)
n=31 Participants
Participants received a single dose of oral capsules of Tacrolimus.
|
Treatment B: Tacrolimus (5 mg) and SZC (15 g)
n=30 Participants
Participants received a single dose of oral capsules of Tacrolimus in combination with oral suspension of SZC.
|
Treatment C: Cyclosporin (100 mg)
n=31 Participants
Participants received a single dose of oral capsules of Cyclosporin.
|
Treatment D: Cyclosporin (100 mg) and SZC (15 g)
n=29 Participants
Participants received a single dose of oral capsules of Cyclosporin in combination with oral suspension of SZC.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Concentration Following Drug Administration (Tmax)
|
1.75 hour
Interval 1.0 to 3.0
|
1.50 hour
Interval 0.75 to 3.0
|
1.50 hour
Interval 0.75 to 2.5
|
1.25 hour
Interval 0.98 to 2.52
|
SECONDARY outcome
Timeframe: 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 cyclosporinPopulation: 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.
Effect of co-administered SZC on the t½λz of tacrolimus and cyclosporin in healthy participants was determined.
Outcome measures
| Measure |
Treatment A: Tacrolimus (5 mg)
n=31 Participants
Participants received a single dose of oral capsules of Tacrolimus.
|
Treatment B: Tacrolimus (5 mg) and SZC (15 g)
n=30 Participants
Participants received a single dose of oral capsules of Tacrolimus in combination with oral suspension of SZC.
|
Treatment C: Cyclosporin (100 mg)
n=31 Participants
Participants received a single dose of oral capsules of Cyclosporin.
|
Treatment D: Cyclosporin (100 mg) and SZC (15 g)
n=29 Participants
Participants received a single dose of oral capsules of Cyclosporin in combination with oral suspension of SZC.
|
|---|---|---|---|---|
|
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz)
|
33.59 hour
Geometric Coefficient of Variation 18.72
|
33.31 hour
Geometric Coefficient of Variation 22.27
|
9.223 hour
Geometric Coefficient of Variation 32.78
|
8.647 hour
Geometric Coefficient of Variation 31.12
|
SECONDARY outcome
Timeframe: 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]Population: All participants who received at least 1 dose of IMP were included in the safety analysis for the study.
Safety and tolerability of co-administration of SZC and tacrolimus/cyclosporin as compared to tacrolimus/cyclosporin alone was assessed.
Outcome measures
| Measure |
Treatment A: Tacrolimus (5 mg)
n=31 Participants
Participants received a single dose of oral capsules of Tacrolimus.
|
Treatment B: Tacrolimus (5 mg) and SZC (15 g)
n=30 Participants
Participants received a single dose of oral capsules of Tacrolimus in combination with oral suspension of SZC.
|
Treatment C: Cyclosporin (100 mg)
n=31 Participants
Participants received a single dose of oral capsules of Cyclosporin.
|
Treatment D: Cyclosporin (100 mg) and SZC (15 g)
n=29 Participants
Participants received a single dose of oral capsules of Cyclosporin in combination with oral suspension of SZC.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any AE
|
7 Participants
|
13 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any AE with outcome = death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any SAE (including events with outcome = death)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any AE leading to discontinuation of IMP
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any AE leading to withdrawal from study
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Treatment A: Tacrolimus (5 mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment B: Tacrolimus (5 mg) and SZC (15 g)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Treatment C: Cyclosporin (100 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment D: Cyclosporin (100 mg) and SZC (15 g)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Tacrolimus (5 mg)
n=31 participants at risk
Participants received a single dose of oral capsules of Tacrolimus.
|
Treatment B: Tacrolimus (5 mg) and SZC (15 g)
n=30 participants at risk
Participants received a single dose of oral capsules of Tacrolimus in combination with oral suspension of SZC.
|
Treatment C: Cyclosporin (100 mg)
n=31 participants at risk
Participants received a single dose of oral capsules of Cyclosporin.
|
Treatment D: Cyclosporin (100 mg) and SZC (15 g)
n=29 participants at risk
Participants received a single dose of oral capsules of Cyclosporin in combination with oral suspension of SZC.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/31 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
3.2%
1/31 • Number of events 1 • 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]
|
0.00%
0/29 • 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]
|
|
Infections and infestations
Rhinitis
|
0.00%
0/31 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Nervous system disorders
Headache
|
9.7%
3/31 • Number of events 3 • 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]
|
13.3%
4/30 • Number of events 4 • 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]
|
3.2%
1/31 • Number of events 1 • 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]
|
6.9%
2/29 • Number of events 2 • 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]
|
|
Eye disorders
Eye swelling
|
3.2%
1/31 • Number of events 1 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Eye disorders
Eyelid pain
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
3.2%
1/31 • Number of events 1 • 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]
|
0.00%
0/29 • 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]
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
3.2%
1/31 • Number of events 1 • 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]
|
0.00%
0/29 • 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]
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/31 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/31 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
3.2%
1/31 • Number of events 1 • 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]
|
0.00%
0/29 • 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]
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/31 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
3.4%
1/29 • Number of events 1 • 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]
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
3.2%
1/31 • Number of events 1 • 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]
|
3.4%
1/29 • Number of events 1 • 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]
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Gastrointestinal disorders
Toothache
|
3.2%
1/31 • Number of events 1 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • Number of events 2 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/31 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
3.4%
1/29 • Number of events 1 • 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]
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
3.2%
1/31 • Number of events 1 • 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]
|
0.00%
0/29 • 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]
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/31 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Number of events 1 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
3.4%
1/29 • Number of events 1 • 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]
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
3.2%
1/31 • Number of events 1 • 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]
|
0.00%
0/29 • 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]
|
|
General disorders
Catheter site pain
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
3.4%
1/29 • Number of events 1 • 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]
|
|
General disorders
Fatigue
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
3.4%
1/29 • Number of events 1 • 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]
|
|
General disorders
Feeling hot
|
3.2%
1/31 • Number of events 2 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/31 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
3.4%
1/29 • Number of events 1 • 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]
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/31 • 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]
|
3.3%
1/30 • Number of events 1 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
|
Injury, poisoning and procedural complications
Sunburn
|
3.2%
1/31 • Number of events 1 • 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]
|
0.00%
0/30 • 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]
|
0.00%
0/31 • 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]
|
0.00%
0/29 • 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]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER