Trial Outcomes & Findings for Bioavailability Study of 2 Oral Formulations of ALXN1840 (NCT NCT04610580)
NCT ID: NCT04610580
Last Updated: 2024-01-16
Results Overview
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via inductively coupled plasma-mass spectroscopy (ICP-MS).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
predose (0.5 hour) and up to 336 hours postdose
Results posted on
2024-01-16
Participant Flow
The study included a 2-way crossover period and a dose-proportionality extension period. Participants were randomized to 1 of the 2 treatment sequences (A-B) or (B-A) in crossover period with washout between. Participants were scheduled to receive either treatment A or B on Day 1 of each dosing period. After a 14-day washout period, participants were rerandomized in dose-proportionality extension period to receive treatment C, D, E, or F.
Participant milestones
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A) First, Then Reference Formulation (Treatment B)
Participants received a single dose of ALXN1840 test formulation (15 milligrams \[mg\]; 12 × 1.25 mg enteric-coated \[EC\] mini-tablets) orally on Day 1 of the first dosing period. Then, participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of the second dosing period.
There was a 14-day washout between the two dosing periods.
|
Crossover: ALXN1840 Reference Formulation (Treatment B) First, Then Test Formulation (Treatment A)
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of the first dosing period. Then, participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of second dosing period.
There was a 14-day washout between the two dosing periods.
|
Dose-proportionality Extension: ALXN1840 2.5 mg (Treatment C)
Participants received a single dose of ALXN1840 2.5 mg (2 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 5 mg (Treatment D)
Participants received a single dose of ALXN1840 5 mg (4 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|---|---|
|
Two-way Crossover Period
STARTED
|
24
|
24
|
0
|
0
|
0
|
0
|
|
Two-way Crossover Period
Received at Least 1 Dose of Study Drug
|
24
|
24
|
0
|
0
|
0
|
0
|
|
Two-way Crossover Period
COMPLETED
|
22
|
22
|
0
|
0
|
0
|
0
|
|
Two-way Crossover Period
NOT COMPLETED
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Washout Before Extension Period
STARTED
|
22
|
22
|
0
|
0
|
0
|
0
|
|
Washout Before Extension Period
COMPLETED
|
22
|
19
|
0
|
0
|
0
|
0
|
|
Washout Before Extension Period
NOT COMPLETED
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Dose-Proportionality Extension Period
STARTED
|
0
|
0
|
10
|
11
|
9
|
11
|
|
Dose-Proportionality Extension Period
Received at Least 1 Dose of Study Drug
|
0
|
0
|
10
|
11
|
9
|
11
|
|
Dose-Proportionality Extension Period
COMPLETED
|
0
|
0
|
10
|
11
|
8
|
11
|
|
Dose-Proportionality Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A) First, Then Reference Formulation (Treatment B)
Participants received a single dose of ALXN1840 test formulation (15 milligrams \[mg\]; 12 × 1.25 mg enteric-coated \[EC\] mini-tablets) orally on Day 1 of the first dosing period. Then, participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of the second dosing period.
There was a 14-day washout between the two dosing periods.
|
Crossover: ALXN1840 Reference Formulation (Treatment B) First, Then Test Formulation (Treatment A)
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of the first dosing period. Then, participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of second dosing period.
There was a 14-day washout between the two dosing periods.
|
Dose-proportionality Extension: ALXN1840 2.5 mg (Treatment C)
Participants received a single dose of ALXN1840 2.5 mg (2 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 5 mg (Treatment D)
Participants received a single dose of ALXN1840 5 mg (4 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|---|---|
|
Two-way Crossover Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Two-way Crossover Period
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Two-way Crossover Period
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Two-way Crossover Period
Other than specified
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Washout Before Extension Period
Other than specified
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Washout Before Extension Period
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Dose-Proportionality Extension Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Bioavailability Study of 2 Oral Formulations of ALXN1840
Baseline characteristics by cohort
| Measure |
Overall Population
n=48 Participants
Crossover: Participants first received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of Period 1 and then after a washout period of 14 days, received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of Period 2. Dose-proportionality extension: Participants received a single dose of ALXN1840 2.5, 5, 10, or 30 mg orally on Day 1.
|
|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 7.85 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
19 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
24 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: predose (0.5 hour) and up to 336 hours postdosePopulation: The Pharmacokinetic/Pharmacodynamic Set for the Two-way Crossover Periods (PKDS-CO) included all participants who received at least 1 dose of ALXN1840 in the Two-way Crossover Periods and had evaluable pharmacokinetic (PK) data for total and/or plasma ultrafiltrate (PUF) Mo (as surrogate measures of ALXN1840 PK) in plasma. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via inductively coupled plasma-mass spectroscopy (ICP-MS).
Outcome measures
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=45 Participants
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=46 Participants
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|
|
Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)
|
227.0186 nanograms (ng)/milliliter (mL)
Geometric Coefficient of Variation 47.5
|
238.2725 nanograms (ng)/milliliter (mL)
Geometric Coefficient of Variation 30.8
|
—
|
—
|
PRIMARY outcome
Timeframe: predose (0.5 hour) and up to 336 hours postdosePopulation: The PKDS-CO included all participants who received at least 1 dose of ALXN1840 in the Two-way Crossover Periods and had evaluable PK data for total and/or PUF molybdenum (as surrogate measures of ALXN1840 PK) in plasma.
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
Outcome measures
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=46 Participants
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=46 Participants
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|
|
Two-way Crossover Period: Cmax for PUF Mo
|
11.758 ng/mL
Geometric Coefficient of Variation 43.7
|
12.120 ng/mL
Geometric Coefficient of Variation 40.7
|
—
|
—
|
PRIMARY outcome
Timeframe: predose (0.5 hour) and up to 336 hours postdosePopulation: The PKDS-CO included all participants who received at least 1 dose of ALXN1840 in the Two-way Crossover Periods and had evaluable PK data for total and/or PUF molybdenum (as surrogate measures of ALXN1840 PK) in plasma. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Outcome measures
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=45 Participants
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=46 Participants
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|
|
Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) For Plasma Total Mo
|
8654.3114 hours*ng/mL
Geometric Coefficient of Variation 46.6
|
9253.7266 hours*ng/mL
Geometric Coefficient of Variation 44.6
|
—
|
—
|
PRIMARY outcome
Timeframe: predose (0.5 hour) and up to 336 hours postdosePopulation: The PKDS-CO included all participants who received at least 1 dose of ALXN1840 in the Two-way Crossover Periods and had evaluable PK data for total and/or PUF molybdenum (as surrogate measures of ALXN1840 PK) in plasma.
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
Outcome measures
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=46 Participants
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=46 Participants
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|
|
Two-way Crossover Period: AUCt for Plasma PUF Mo
|
766.7655 hours*ng/mL
Geometric Coefficient of Variation 25.6
|
811.7275 hours*ng/mL
Geometric Coefficient of Variation 27.2
|
—
|
—
|
PRIMARY outcome
Timeframe: predose (0.5 hour) and up to 336 hours postdosePopulation: The PKDS-CO included all participants who received at least 1 dose of ALXN1840 in the Two-way Crossover Periods and had evaluable PK data for total and/or PUF molybdenum (as surrogate measures of ALXN1840 PK) in plasma. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Outcome measures
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=32 Participants
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=35 Participants
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|
|
Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo
|
10149.7531 hours*ng/mL
Geometric Coefficient of Variation 29.2
|
10068.8862 hours*ng/mL
Geometric Coefficient of Variation 23.0
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0.5 hour) and up to 336 hours postdosePopulation: The Pharmacokinetic/Pharmacodynamic Set for the Dose-Proportionality Extension Period (PKDS-E) included all participants who receive at least 1 dose of ALXN1840 in the Dose-Proportionality Extension Period and had evaluable PK data for total and/or PUF molybdenum (as surrogate measures of ALXN1840 PK) in plasma.
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Outcome measures
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=10 Participants
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=11 Participants
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
n=9 Participants
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
n=11 Participants
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|
|
Dose-Proportionality Extension Period: Cmax For Plasma Total Mo
|
41.0441 ng/mL
Standard Deviation 19.48739
|
104.4313 ng/mL
Standard Deviation 52.55264
|
199.4759 ng/mL
Standard Deviation 55.17849
|
396.0000 ng/mL
Standard Deviation 190.18412
|
SECONDARY outcome
Timeframe: predose (0.5 hour) and up to 336 hours postdosePopulation: The PKDS-E included all participants who receive at least 1 dose of ALXN1840 in the Dose-Proportionality Extension Period and had evaluable PK data for total and/or PUF molybdenum (as surrogate measures of ALXN1840 PK) in plasma.
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
Outcome measures
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=10 Participants
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=11 Participants
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
n=9 Participants
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
n=11 Participants
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|
|
Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo
|
8.505 ng/mL
Standard Deviation 9.3638
|
9.341 ng/mL
Standard Deviation 11.6589
|
16.557 ng/mL
Standard Deviation 20.7835
|
25.945 ng/mL
Standard Deviation 11.0632
|
SECONDARY outcome
Timeframe: predose (0.5 hour) and up to 336 hours postdosePopulation: The PKDS-E included all participants who receive at least 1 dose of ALXN1840 in the Dose-Proportionality Extension Period and had evaluable PK data for total and/or PUF molybdenum (as surrogate measures of ALXN1840 PK) in plasma.
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Outcome measures
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=10 Participants
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=11 Participants
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
n=9 Participants
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
n=11 Participants
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|
|
Dose-Proportionality Extension Period: AUCt For Plasma Total Mo
|
1677.8616 hours*ng/mL
Standard Deviation 736.42903
|
4053.6004 hours*ng/mL
Standard Deviation 1601.44215
|
7439.1004 hours*ng/mL
Standard Deviation 2213.01844
|
16778.1770 hours*ng/mL
Standard Deviation 4707.76069
|
SECONDARY outcome
Timeframe: predose (0.5 hour) and up to 336 hours postdosePopulation: The PKDS-E included all participants who receive at least 1 dose of ALXN1840 in the Dose-Proportionality Extension Period and had evaluable PK data for total and/or PUF molybdenum (as surrogate measures of ALXN1840 PK) in plasma.
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
Outcome measures
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=10 Participants
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=11 Participants
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
n=9 Participants
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
n=11 Participants
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|
|
Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo
|
584.5782 hours*ng/mL
Standard Deviation 177.03965
|
826.2629 hours*ng/mL
Standard Deviation 623.23702
|
805.6937 hours*ng/mL
Standard Deviation 449.64768
|
976.4214 hours*ng/mL
Standard Deviation 220.56479
|
SECONDARY outcome
Timeframe: predose (0.5 hour) and up to 336 hours postdosePopulation: The PKDS-E included all participants who receive at least 1 dose of ALXN1840 in the Dose-Proportionality Extension Period and had evaluable PK data for total and/or PUF molybdenum (as surrogate measures of ALXN1840 PK) in plasma. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Only data for Treatments D, E, and F were collected for this Outcome Measure.
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Outcome measures
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=6 Participants
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=6 Participants
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
n=10 Participants
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|
|
Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo
|
4920.5103 hours*ng/mL
Standard Deviation 1035.21136
|
9057.1367 hours*ng/mL
Standard Deviation 1345.89511
|
17842.1736 hours*ng/mL
Standard Deviation 5496.94190
|
—
|
Adverse Events
Crossover: ALXN1840 Test Formulation (Treatment A)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Crossover: ALXN1840 Reference Formulation (Treatment B)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Dose-proportionality Extension: ALXN1840 2.5 mg (Treatment C)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose-proportionality Extension: ALXN1840 5 mg (Treatment D
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crossover: ALXN1840 Test Formulation (Treatment A)
n=46 participants at risk
Participants received a single dose of ALXN1840 test formulation (15 mg; 12 × 1.25 mg EC mini-tablets) orally on Day 1 of each dosing period in a crossover design.
|
Crossover: ALXN1840 Reference Formulation (Treatment B)
n=46 participants at risk
Participants received a single dose of ALXN1840 reference formulation (15 mg EC tablet) orally on Day 1 of each dosing period in a crossover deign.
|
Dose-proportionality Extension: ALXN1840 2.5 mg (Treatment C)
n=10 participants at risk
Participants received a single dose of ALXN1840 2.5 mg (2 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 5 mg (Treatment D
n=11 participants at risk
Participants received a single dose of ALXN1840 5 mg (4 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)
n=9 participants at risk
Participants received a single dose of ALXN1840 10 mg (8 × 1.25 mg EC mini-tablets) orally on Day 1.
|
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)
n=11 participants at risk
Participants received a single dose of ALXN1840 30 mg (24 × 1.25 mg EC mini-tablets) orally on Day 1.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
13.0%
6/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
6.5%
3/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
10.0%
1/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
22.2%
2/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
18.2%
2/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Nervous system disorders
Hypoaesthesia
|
4.3%
2/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
11.1%
1/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Nervous system disorders
Syncope
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Nervous system disorders
Tremor
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
General disorders
Catheter site pain
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
6.5%
3/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
General disorders
Catheter site bruise
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
General disorders
Catheter site paraesthesia
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
General disorders
Feeling abnormal
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
General disorders
Pyrexia
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
General disorders
Vessel puncture site pain
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
General disorders
Vessel puncture site reaction
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
8.7%
4/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
4.3%
2/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
4.3%
2/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.5%
3/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Reproductive system and breast disorders
Premenstrual pain
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
10.0%
1/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Infections and infestations
Folliculitis
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Infections and infestations
Viral infection
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
2.2%
1/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
10.0%
1/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
11.1%
1/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
General disorders
Injection site thrombosis
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
General disorders
Physical deconditioning
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillolith
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
10.0%
1/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
|
Vascular disorders
Haematoma
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/46 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/10 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
0.00%
0/9 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
9.1%
1/11 • Baseline up to Day 15
The Safety Set included all participants who received at least 1 dose of ALXN1840 and are presented by the treatment received at the time of the adverse event reporting.
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: +1 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place