Trial Outcomes & Findings for A Study to Assess the Pharmacokinetics and Safety of Different Forms and Formulations of AZD9496 in Healthy Subjects (NCT NCT02780713)
NCT ID: NCT02780713
Last Updated: 2021-08-25
Results Overview
To evaluate maximum observed plasma concentration (Cmax) for AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Regular Pharmacokinetic measurement Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment period
Results posted on
2021-08-25
Participant Flow
At the United States (US, 1 site), 14 healthy participants were treated with AZD9496 (1 dose at fasted state) in 5 treatment periods: Formulation Variants A, B \& C (doses 1,3, \& 4), reference (dose 2) and formulation Variant B (dose 5). Each subject was involved in the study for approximately 10 to 12 weeks.
A screening period of maximum of -28 days.
Participant milestones
| Measure |
Treatment Period 1
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Period 1: Variant A (100mg)
STARTED
|
14
|
0
|
0
|
0
|
0
|
|
Period 1: Variant A (100mg)
COMPLETED
|
14
|
0
|
0
|
0
|
0
|
|
Period 1: Variant A (100mg)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Reference (100mg)
STARTED
|
0
|
14
|
0
|
0
|
0
|
|
Period 2: Reference (100mg)
COMPLETED
|
0
|
14
|
0
|
0
|
0
|
|
Period 2: Reference (100mg)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 3: Variant B (100mg)
STARTED
|
0
|
0
|
14
|
0
|
0
|
|
Period 3: Variant B (100mg)
COMPLETED
|
0
|
0
|
12
|
0
|
0
|
|
Period 3: Variant B (100mg)
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
|
Period 4: Variant C (100mg)
STARTED
|
0
|
0
|
0
|
12
|
0
|
|
Period 4: Variant C (100mg)
COMPLETED
|
0
|
0
|
0
|
12
|
0
|
|
Period 4: Variant C (100mg)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 5: Variant B (300mg)
STARTED
|
0
|
0
|
0
|
0
|
12
|
|
Period 5: Variant B (300mg)
COMPLETED
|
0
|
0
|
0
|
0
|
12
|
|
Period 5: Variant B (300mg)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Period 1
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Period 3: Variant B (100mg)
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
A Study to Assess the Pharmacokinetics and Safety of Different Forms and Formulations of AZD9496 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Participants
n=14 Participants
All enrolled participants who received at least one dose of AZD9496.
|
|---|---|
|
Age, Continuous
|
49.6 Years
STANDARD_DEVIATION 6.22 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
14 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Regular Pharmacokinetic measurement Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: Safety set with 1 primary PK parameter for AZD9496 calculable for Treatment Period 2 and 1 other period. For AUC 0-inf, a predefined R2adj \>0.8 (the goodness of fit parameter for regression estimate of elimination rate constant lambda z used in the AUC 0-inf calculation) was used to determine if the individual AUC estimate was reportable.
To evaluate maximum observed plasma concentration (Cmax) for AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation.
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) for AZD9496 and Its Metabolites at Each Treatment Period.
M5
|
1.102 ng/mL
Geometric Coefficient of Variation 85.27
|
7.409 ng/mL
Geometric Coefficient of Variation 75.18
|
2.454 ng/mL
Geometric Coefficient of Variation 80.35
|
1.520 ng/mL
Geometric Coefficient of Variation 42.67
|
11.71 ng/mL
Geometric Coefficient of Variation 49.60
|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) for AZD9496 and Its Metabolites at Each Treatment Period.
AZD9496
|
64.85 ng/mL
Geometric Coefficient of Variation 73.54
|
381.0 ng/mL
Geometric Coefficient of Variation 55.83
|
138.2 ng/mL
Geometric Coefficient of Variation 75.35
|
91.83 ng/mL
Geometric Coefficient of Variation 52.13
|
550.9 ng/mL
Geometric Coefficient of Variation 41.85
|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) for AZD9496 and Its Metabolites at Each Treatment Period.
M3
|
10.30 ng/mL
Geometric Coefficient of Variation 98.93
|
62.98 ng/mL
Geometric Coefficient of Variation 76.91
|
23.56 ng/mL
Geometric Coefficient of Variation 74.30
|
14.47 ng/mL
Geometric Coefficient of Variation 39.01
|
98.72 ng/mL
Geometric Coefficient of Variation 54.80
|
PRIMARY outcome
Timeframe: Regular Pharmacokinetic measurement: At Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: Safety set with 1 primary PK parameter for AZD9496 calculable for Treatment Period 2 and 1 other period. For AUC 0-inf, a predefined R2adj \>0.8 (the goodness of fit parameter for regression estimate of elimination rate constant lambda z used in the AUC 0-inf calculation) was used to determine if the individual AUC estimate was reportable.
To evaluate the area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUC (0-t) of AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Curve From Time Zero to Time With Last Observation (AUC0-t) for AZD9496 and Its Metabolites at Each Treatment Period
AZD9496
|
383.4 ng*h/mL
Geometric Coefficient of Variation 60.54
|
1207 ng*h/mL
Geometric Coefficient of Variation 53.01
|
677.8 ng*h/mL
Geometric Coefficient of Variation 50.08
|
523.0 ng*h/mL
Geometric Coefficient of Variation 26.77
|
2322 ng*h/mL
Geometric Coefficient of Variation 32.12
|
|
Pharmacokinetics: Area Under the Curve From Time Zero to Time With Last Observation (AUC0-t) for AZD9496 and Its Metabolites at Each Treatment Period
M3
|
46.71 ng*h/mL
Geometric Coefficient of Variation 124.65
|
196.6 ng*h/mL
Geometric Coefficient of Variation 80.92
|
111.7 ng*h/mL
Geometric Coefficient of Variation 62.00
|
78.23 ng*h/mL
Geometric Coefficient of Variation 65.96
|
411.3 ng*h/mL
Geometric Coefficient of Variation 57.56
|
|
Pharmacokinetics: Area Under the Curve From Time Zero to Time With Last Observation (AUC0-t) for AZD9496 and Its Metabolites at Each Treatment Period
M5
|
4.872 ng*h/mL
Geometric Coefficient of Variation 98.91
|
23.11 ng*h/mL
Geometric Coefficient of Variation 73.68
|
11.05 ng*h/mL
Geometric Coefficient of Variation 62.20
|
7.614 ng*h/mL
Geometric Coefficient of Variation 57.93
|
46.42 ng*h/mL
Geometric Coefficient of Variation 49.23
|
PRIMARY outcome
Timeframe: Regular Pharmacokinetic measurement Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: Safety set with 1 primary PK parameter for AZD9496 calculable for Treatment Period 2 and 1 other period. For AUC 0-inf, a predefined R2adj \>0.8 (the goodness of fit parameter for regression estimate of elimination rate constant lambda z used in the AUC 0-inf calculation) was used to determine if the individual AUC estimate was reportable.
To evaluate maximum plasma concentration (Cmax) of capsule variants by comparing with reference AZD9496
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=12 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) for Variant A, B and C of AZD9496 Compared to the AZD9496 Reference
|
0.1702 Ratio
Geometric Coefficient of Variation 90.94
|
0.3440 Ratio
Geometric Coefficient of Variation 110.40
|
0.2285 Ratio
Geometric Coefficient of Variation 89.40
|
—
|
—
|
PRIMARY outcome
Timeframe: Regular Pharmacokinetic measurement Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: Safety set with 1 primary PK parameter for AZD9496 calculable for Treatment Period 2 and 1 other period. For AUC 0-inf, a predefined R2adj \>0.8 (the goodness of fit parameter for regression estimate of elimination rate constant lambda z used in the AUC 0-inf calculation) was used to determine if the individual AUC estimate was reportable.
To evaluate area under curve from time zero to time with last observation (AUC0-t) of variants by comparing with reference AZD9496
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=12 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Curve From Time Zero to Time With Last Observation (AUC0-t) for Variant A, B and C of AZD9496 Compared to the AZD9496 Reference
|
0.3175 Ratio
Geometric Coefficient of Variation 46.35
|
0.5227 Ratio
Geometric Coefficient of Variation 50.95
|
0.4033 Ratio
Geometric Coefficient of Variation 33.15
|
—
|
—
|
PRIMARY outcome
Timeframe: Regular Pharmacokinnetic measurement Pre-dose, 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24, and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: Safety set with 1 primary PK parameter for AZD9496 calculable for Treatment Period 2 and 1 other period. For AUC 0-inf, a predefined R2adj \>0.8 (the goodness of fit parameter for regression estimate of elimination rate constant lambda z used in the AUC 0-inf calculation) was used to determine if the individual AUC estimate was reportable. Data not available for all participants.
To evaluate area under the curve from time zero to time infinity (AUC 0-infinity) of variants by comparing with reference AZD9496
Outcome measures
| Measure |
Treatment Period 1
n=1 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=4 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=4 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Curve From Time Zero to Infinity for Variant A, B and C of AZD9496 Compared to the AZD9496 Reference
|
NA Ratio
Geometric Coefficient of Variation NA
Data for n=1 available.
|
0.6186 Ratio
Geometric Coefficient of Variation 37.26
|
0.4055 Ratio
Geometric Coefficient of Variation 48.13
|
—
|
—
|
PRIMARY outcome
Timeframe: Regular pharmacokinetic measurement pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: Safety set with 1 primary PK parameter for AZD9496 calculable for Treatment Period 2 and 1 other period. For AUC 0-inf, a predefined R2adj \>0.8 (the goodness of fit parameter for regression estimate of elimination rate constant lambda z used in the AUC 0-inf calculation) was used to determine if the individual AUC estimate was reportable. Data not available for all participants.
To evaluate area under the curve from time zero to infinity (AUC 0-infinity) for AZD9496 and its metabolites
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Curve From Time Zero to Infinity (AUC 0-infinity) for AZD9496 and Metabolites at Each Treatment Period
AZD9496
|
NA ng*h/mL
Geometric Coefficient of Variation NA
Data could not be calculated due to n=1.
|
1238 ng*h/mL
Geometric Coefficient of Variation 46.88
|
968.1 ng*h/mL
Geometric Coefficient of Variation 30.12
|
604.7 ng*h/mL
Geometric Coefficient of Variation 18.37
|
2790 ng*h/mL
Geometric Coefficient of Variation 22.97
|
|
Pharmacokinetics: Area Under the Curve From Time Zero to Infinity (AUC 0-infinity) for AZD9496 and Metabolites at Each Treatment Period
M3
|
—
|
253.2 ng*h/mL
Geometric Coefficient of Variation 58.97
|
99.9 ng*h/mL
Geometric Coefficient of Variation 64.10
|
56.9 ng*h/mL
Geometric Coefficient of Variation 30.78
|
420.6 ng*h/mL
Geometric Coefficient of Variation 76.41
|
|
Pharmacokinetics: Area Under the Curve From Time Zero to Infinity (AUC 0-infinity) for AZD9496 and Metabolites at Each Treatment Period
M5
|
5.93 ng*h/mL
Geometric Coefficient of Variation 95.53
|
24.09 ng*h/mL
Geometric Coefficient of Variation 76.00
|
11.15 ng*h/mL
Geometric Coefficient of Variation 65.47
|
—
|
54.84 ng*h/mL
Geometric Coefficient of Variation 47.54
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters for AZD9496 could be calculated for at least Treatment Period 2 and 1 other treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To evaluate time to reach maximum observed plasma concentration (Tmax) for AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation.
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for AZD9496 and Its Metabolites at Each Treatment Period.
AZD9496
|
4.25 Hours
Interval 1.5 to 5.6
|
2.25 Hours
Interval 1.5 to 3.48
|
3.52 Hours
Interval 2.5 to 5.03
|
4.25 Hours
Interval 2.5 to 5.02
|
4.25 Hours
Interval 2.5 to 6.05
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for AZD9496 and Its Metabolites at Each Treatment Period.
M3
|
4.50 Hours
Interval 2.0 to 5.6
|
2.50 Hours
Interval 1.5 to 4.67
|
3.77 Hours
Interval 2.98 to 6.02
|
5.00 Hours
Interval 3.0 to 5.12
|
4.26 Hours
Interval 2.5 to 6.05
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for AZD9496 and Its Metabolites at Each Treatment Period.
M5
|
4.50 Hours
Interval 2.0 to 5.6
|
2.50 Hours
Interval 1.5 to 4.05
|
4.00 Hours
Interval 2.5 to 5.5
|
4.99 Hours
Interval 3.0 to 5.12
|
4.51 Hours
Interval 2.5 to 6.05
|
SECONDARY outcome
Timeframe: Regular Pharmacokinetic measurement Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters for AZD9496 could be calculated for at least Treatment Period 2 and 1 other treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data. Data not available for all participants.
To evaluate effective half-life (t½,eff), for AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation.
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Effective Half-life ( t½,Eff) for AZD9496 and Its Metabolites at Each Treatment Period
AZD9496
|
1.34 Hours
Standard Deviation 0.45
|
1.11 Hours
Standard Deviation 0.15
|
1.51 Hours
Standard Deviation 0.68
|
1.56 Hours
Standard Deviation 0.36
|
1.36 Hours
Standard Deviation 0.31
|
|
Effective Half-life ( t½,Eff) for AZD9496 and Its Metabolites at Each Treatment Period
M3
|
1.16 Hours
Standard Deviation 0.36
|
1.09 Hours
Standard Deviation 0.17
|
2.02 Hours
Standard Deviation 1.84
|
1.57 Hours
Standard Deviation 0.47
|
1.28 Hours
Standard Deviation 0.28
|
|
Effective Half-life ( t½,Eff) for AZD9496 and Its Metabolites at Each Treatment Period
M5
|
1.15 Hours
Standard Deviation 0.27
|
1.06 Hours
Standard Deviation 0.15
|
1.54 Hours
Standard Deviation 0.70
|
1.42 Hours
Standard Deviation 0.36
|
1.23 Hours
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Regular Pharmacokinetic measurement Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters for AZD9496 could be calculated for at least Treatment Period 2 and 1 other treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data. Data not available for all participants.
To evaluate metabolite to parent ratios (MRAUC0-t, MRCmax, MRAUC) at each treatment period.
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Metabolite to Parent Ratios (MRAUC0-t, MRCmax, MRAUC) at Each Treatment Period.
M3 - MRAUC(0-t)
|
0.122 Ratio
Geometric Coefficient of Variation 48.12
|
0.163 Ratio
Geometric Coefficient of Variation 30.75
|
0.165 Ratio
Geometric Coefficient of Variation 33.49
|
0.150 Ratio
Geometric Coefficient of Variation 41.38
|
0.177 Ratio
Geometric Coefficient of Variation 30.28
|
|
Metabolite to Parent Ratios (MRAUC0-t, MRCmax, MRAUC) at Each Treatment Period.
M5 - MRAUC(0-t)
|
0.013 Ratio
Geometric Coefficient of Variation 33.81
|
0.019 Ratio
Geometric Coefficient of Variation 22.07
|
0.016 Ratio
Geometric Coefficient of Variation 23.06
|
0.015 Ratio
Geometric Coefficient of Variation 32.71
|
0.020 Ratio
Geometric Coefficient of Variation 21.32
|
|
Metabolite to Parent Ratios (MRAUC0-t, MRCmax, MRAUC) at Each Treatment Period.
M3 - MRCmax
|
0.159 Ratio
Geometric Coefficient of Variation 37.68
|
0.165 Ratio
Geometric Coefficient of Variation 25.97
|
0.170 Ratio
Geometric Coefficient of Variation 30.68
|
0.158 Ratio
Geometric Coefficient of Variation 36.29
|
0.179 Ratio
Geometric Coefficient of Variation 27.25
|
|
Metabolite to Parent Ratios (MRAUC0-t, MRCmax, MRAUC) at Each Treatment Period.
M5 - MRCmax
|
0.017 Ratio
Geometric Coefficient of Variation 30.16
|
0.019 Ratio
Geometric Coefficient of Variation 21.01
|
0.018 Ratio
Geometric Coefficient of Variation 31.23
|
0.017 Ratio
Geometric Coefficient of Variation 33.79
|
0.022 Ratio
Geometric Coefficient of Variation 20.22
|
|
Metabolite to Parent Ratios (MRAUC0-t, MRCmax, MRAUC) at Each Treatment Period.
M3 - MRAUC
|
—
|
0.173 Ratio
Geometric Coefficient of Variation 21.11
|
0.172 Ratio
Geometric Coefficient of Variation 7.81
|
—
|
0.193 Ratio
Geometric Coefficient of Variation 39.07
|
|
Metabolite to Parent Ratios (MRAUC0-t, MRCmax, MRAUC) at Each Treatment Period.
M5 - MRAUC
|
—
|
0.020 Ratio
Geometric Coefficient of Variation 14.91
|
0.018 Ratio
Geometric Coefficient of Variation 10.90
|
—
|
0.021 Ratio
Geometric Coefficient of Variation 26.57
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: Safety set with 1 primary PK parameter for AZD9496 calculable for Treatment Period 2 and 1 other period. For AUC 0-inf, a predefined R2adj \>0.8 (the goodness of fit parameter for regression estimate of elimination rate constant lambda z used in the AUC 0-inf calculation) was used to determine if the individual AUC estimate was reportable. Data not available for all participants. Where less than 3 participants contribute data, the PK parameter was not calculated.
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: AUC From Time Zero to 12 and 24 Hours Post-dose for AZD9496 and Its Metabolites at Each Treatment Period
M5 AUC 0-24 Hours
|
7.417 ng*h/mL
Geometric Coefficient of Variation 65.09
|
NA ng*h/mL
Geometric Coefficient of Variation NA
Not calculated as n=1.
|
10.09 ng*h/mL
Geometric Coefficient of Variation 60.5
|
8.32 ng*h/mL
Geometric Coefficient of Variation 27.76
|
46.57 ng*h/mL
Geometric Coefficient of Variation 49.04
|
|
Pharmacokinetics: AUC From Time Zero to 12 and 24 Hours Post-dose for AZD9496 and Its Metabolites at Each Treatment Period
AZD9496 AUC 0-12 Hours
|
256.2 ng*h/mL
Geometric Coefficient of Variation 65.67
|
1194 ng*h/mL
Geometric Coefficient of Variation 51.83
|
515.3 ng*h/mL
Geometric Coefficient of Variation 57.4
|
326.3 ng*h/mL
Geometric Coefficient of Variation 36.18
|
1920 ng*h/mL
Geometric Coefficient of Variation 38.5
|
|
Pharmacokinetics: AUC From Time Zero to 12 and 24 Hours Post-dose for AZD9496 and Its Metabolites at Each Treatment Period
AZD9496 AUC 0-24 Hours
|
299.9 ng*h/mL
Geometric Coefficient of Variation 60.13
|
1306 ng*h/mL
Geometric Coefficient of Variation 44.9
|
614.8 ng*h/mL
Geometric Coefficient of Variation 49.08
|
411.7 ng*h/mL
Geometric Coefficient of Variation 28
|
2130 ng*h/mL
Geometric Coefficient of Variation 36.83
|
|
Pharmacokinetics: AUC From Time Zero to 12 and 24 Hours Post-dose for AZD9496 and Its Metabolites at Each Treatment Period
M3 AUC 0-12 Hours
|
63.02 ng*h/mL
Geometric Coefficient of Variation 72.17
|
377.3 ng*h/mL
Geometric Coefficient of Variation 23.86
|
91.52 ng*h/mL
Geometric Coefficient of Variation 57.32
|
62.41 ng*h/mL
Geometric Coefficient of Variation 33.9
|
391.6 ng*h/mL
Geometric Coefficient of Variation 46.7
|
|
Pharmacokinetics: AUC From Time Zero to 12 and 24 Hours Post-dose for AZD9496 and Its Metabolites at Each Treatment Period
M3 AUC 0-24 Hours
|
73.26 ng*h/mL
Geometric Coefficient of Variation 71.57
|
NA ng*h/mL
Geometric Coefficient of Variation NA
Not calculated as n=1.
|
114.9 ng*h/mL
Geometric Coefficient of Variation 47.43
|
91.49 ng*h/mL
Geometric Coefficient of Variation 32.74
|
490.4 ng*h/mL
Geometric Coefficient of Variation 47.82
|
|
Pharmacokinetics: AUC From Time Zero to 12 and 24 Hours Post-dose for AZD9496 and Its Metabolites at Each Treatment Period
M5 AUC 0-12 Hours
|
6.162 ng*h/mL
Geometric Coefficient of Variation 78.95
|
37.83 ng*h/mL
Geometric Coefficient of Variation 33.76
|
8.646 ng*h/mL
Geometric Coefficient of Variation 74.31
|
5.953 ng*h/mL
Geometric Coefficient of Variation 31.78
|
40.2 ng*h/mL
Geometric Coefficient of Variation 49.71
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 12, hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4) of each treatment periodPopulation: Safety set with 1 primary PK parameter for AZD9496 calculable for Treatment Period 2 and 1 other period. For AUC 0-inf, a predefined R2adj \>0.8 (the goodness of fit parameter for regression estimate of elimination rate constant lambda z used in the AUC 0-inf calculation) was used to determine if the individual AUC estimate was reportable. Data not available for all participants. Where less than 3 participants contribute data, the PK parameter was not calculated.
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: The Terminal Elimination Half-life (t½,λz) for AZD9496 and Its Metabolites at Each Treatment Period
AZD9496
|
NA Hours
Standard Deviation NA
Not calculated as n=1.
|
2.59 Hours
Standard Deviation 1.75
|
8.95 Hours
Standard Deviation 7.55
|
15.66 Hours
Standard Deviation 4.47
|
9.65 Hours
Standard Deviation 3.96
|
|
Pharmacokinetics: The Terminal Elimination Half-life (t½,λz) for AZD9496 and Its Metabolites at Each Treatment Period
M3
|
NA Hours
Standard Deviation NA
Not calculated as n=2.
|
1.34 Hours
Standard Deviation 0.39
|
2.19 Hours
Standard Deviation 2.13
|
1.89 Hours
Standard Deviation 0.57
|
3.69 Hours
Standard Deviation 2.70
|
|
Pharmacokinetics: The Terminal Elimination Half-life (t½,λz) for AZD9496 and Its Metabolites at Each Treatment Period
M5
|
1.18 Hours
Standard Deviation 0.47
|
1.89 Hours
Standard Deviation 1.35
|
1.41 Hours
Standard Deviation 0.55
|
—
|
5.06 Hours
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4Population: Too few data points available. Data not calculated for Vss/F for M3 and M5 .
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Apparent Volume of Distribution (Vss/F) of AZD9496 and Its Metabolites at Each Treatment Period
AZD9496
|
—
|
277.5 L
Standard Deviation 127.3
|
1291 L
Standard Deviation 1097
|
3495 L
Standard Deviation 1532
|
920.7 L
Standard Deviation 392.1
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4Population: Too few data points available. CL/F not calculated for M3 and M5. Where less than 3 participants contribute data, the PK parameter was not calculated.
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Apparent Oral Clearance (CL/F) of AZD9496 and Its Metabolites at Each Treatment Period
AZD9496
|
NA L/h
Standard Deviation NA
Not calculated as n=1.
|
80.8 L/h
Standard Deviation 39.8
|
107.0 L/h
Standard Deviation 32.7
|
167.5 L/h
Standard Deviation 30.1
|
110.0 L/h
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4Population: Too few data points available and so λz not calculated for all participants. Where less than 3 participants contribute data, the PK parameter was not calculated.
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Apparent Terminal Elimination Rate Constant (λz) of AZD9496 and Its Metabolites at Each Treatment Period
AZD9496
|
NA T-1
Geometric Coefficient of Variation NA
Not calculated as n=1.
|
0.3132 T-1
Geometric Coefficient of Variation 58.96
|
0.1236 T-1
Geometric Coefficient of Variation 183.17
|
0.0459 T-1
Geometric Coefficient of Variation 31.05
|
0.0777 T-1
Geometric Coefficient of Variation 46.67
|
|
Pharmacokinetics: Apparent Terminal Elimination Rate Constant (λz) of AZD9496 and Its Metabolites at Each Treatment Period
M3
|
NA T-1
Geometric Coefficient of Variation NA
Not calculated as n=2.
|
0.537 T-1
Geometric Coefficient of Variation 29.69
|
0.422 T-1
Geometric Coefficient of Variation 88.14
|
0.380 T-1
Geometric Coefficient of Variation 34.17
|
0.230 T-1
Geometric Coefficient of Variation 75.62
|
|
Pharmacokinetics: Apparent Terminal Elimination Rate Constant (λz) of AZD9496 and Its Metabolites at Each Treatment Period
M5
|
0.618 T-1
Geometric Coefficient of Variation 38.36
|
0.426 T-1
Geometric Coefficient of Variation 55.48
|
0.526 T-1
Geometric Coefficient of Variation 41.77
|
—
|
0.154 T-1
Geometric Coefficient of Variation 65.20
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4Population: Data points not available for all participants. MRT not calculated for M3 and M5 metabolites. Where less than 3 participants contribute data, the PK parameter was not calculated.
Outcome measures
| Measure |
Treatment Period 1
n=14 Participants
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 Participants
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 Participants
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 Participants
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 Participants
Participants received AZD9496 - Variant B (300 mg).
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Mean Residence Time (MRT) of AZD9496 and Its Metabolites at Each Treatment Period
AZD9496
|
NA Hours
Geometric Coefficient of Variation NA
Not calculated as n=1.
|
3.122 Hours
Geometric Coefficient of Variation 23.77
|
8.992 Hours
Geometric Coefficient of Variation 107.76
|
19.73 Hours
Geometric Coefficient of Variation 52.63
|
7.939 Hours
Geometric Coefficient of Variation 29.73
|
Adverse Events
Treatment Period 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment Period 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment Period 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment Period 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Period 5
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
All Participants
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Period 1
n=14 participants at risk
Participants received AZD9496 - Variant A (100 mg).
|
Treatment Period 2
n=14 participants at risk
Participants received AZD9496 - Reference (100 mg).
|
Treatment Period 3
n=12 participants at risk
Participants received AZD9496 - Variant B (100 mg).
|
Treatment Period 4
n=12 participants at risk
Participants received AZD9496 - Variant C (100 mg).
|
Treatment Period 5
n=12 participants at risk
Participants received AZD9496 - Variant B (300 mg).
|
All Participants
n=14 participants at risk
All enrolled participants who received at least one dose of AZD9496.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/14 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
7.1%
1/14 • Number of events 1 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/14 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
8.3%
1/12 • Number of events 1 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
7.1%
1/14 • Number of events 1 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
|
Infections and infestations
Body tinea
|
0.00%
0/14 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/14 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
8.3%
1/12 • Number of events 1 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
7.1%
1/14 • Number of events 1 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
7.1%
1/14 • Number of events 1 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/14 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
7.1%
1/14 • Number of events 1 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
7.1%
1/14 • Number of events 1 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
0.00%
0/12 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
7.1%
1/14 • Number of events 1 • From enrollment until the final follow-up visit (5 to 7 days after last dose)
Serious adverse events (SAEs) were recorded from the signing of the informed consent and adverse events (AEs) were recorded from enrollment until the final follow-up visit. Note: A total of 4 participants reported at least one AE. Of the 4 participants, 1 participant reported two AEs "Rhinorrhoea" and "Body tinea" associated with treatments Variant A and B, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All of the study information and data collected during the study are confidential and the property of AstraZeneca. After completion of the study, the investigator may prepare a joint publication with AstraZeneca. The investigator must undertake not to submit any part of the individual data from this clinical study protocol for publication without prior consent of AstraZeneca at a mutually agreed time.
- Publication restrictions are in place
Restriction type: OTHER