Trial Outcomes & Findings for A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults (NCT NCT05319899)
NCT ID: NCT05319899
Last Updated: 2023-08-01
Results Overview
AUC0-t was calculated by the linear trapezoidal method.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Predose (0 hour) up to 192 hours postdose
Results posted on
2023-08-01
Participant Flow
Participants were randomized to one of 6 treatment sequences.
Participant milestones
| Measure |
Treatment Sequence 1: ABC
Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 milligrams (mg) (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 2 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) once daily (QD) in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Treatment Sequence 2: ACB
Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Treatment Sequence 3: BAC
Participants received each treatment on 1 occasion:
Period 1 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Treatment Sequence 4: BCA
Participants received each treatment on 1 occasion:
Period 1 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Treatment Sequence 5: CAB
Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 3 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Treatment Sequence 6: CBA
Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1: ABC
n=3 Participants
Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 2 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Treatment Sequence 2: ACB
n=3 Participants
Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Treatment Sequence 3: BAC
n=3 Participants
Participants received each treatment on 1 occasion:
Period 1 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Treatment Sequence 4: BCA
n=3 Participants
Participants received each treatment on 1 occasion:
Period 1 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Treatment Sequence 5: CAB
n=3 Participants
Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 3 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Treatment Sequence 6: CBA
n=3 Participants
Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 4.16 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 10.21 • n=7 Participants
|
25.7 years
STANDARD_DEVIATION 2.52 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 14.11 • n=4 Participants
|
35.0 years
STANDARD_DEVIATION 17.69 • n=21 Participants
|
40.0 years
STANDARD_DEVIATION 12.53 • n=8 Participants
|
33.1 years
STANDARD_DEVIATION 10.75 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Predose (0 hour) up to 192 hours postdosePopulation: Pharmacokinetic (PK) analysis population included all participants who completed at least 2 periods of the study and had sufficient data for the determination of PK parameters.
AUC0-t was calculated by the linear trapezoidal method.
Outcome measures
| Measure |
Treatment A: ALXN1840 (Fasted)
n=18 Participants
ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
|
Treatment B: Omeprazole + ALXN1840 (Fasted)
n=18 Participants
Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
|
Treatment C: Omeprazole + ALXN1840 (Fed)
n=18 Participants
Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)
|
14531 hours*ng/mL
Standard Deviation 6886
|
18537 hours*ng/mL
Standard Deviation 4303
|
14536 hours*ng/mL
Standard Deviation 3663
|
PRIMARY outcome
Timeframe: Predose (0 hour) up to 192 hours postdosePopulation: PK analysis population included all participants who completed at least 2 periods of the study and had sufficient data for the determination of PK parameters.
Outcome measures
| Measure |
Treatment A: ALXN1840 (Fasted)
n=18 Participants
ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
|
Treatment B: Omeprazole + ALXN1840 (Fasted)
n=18 Participants
Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
|
Treatment C: Omeprazole + ALXN1840 (Fed)
n=18 Participants
Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
|
|---|---|---|---|
|
Maximum Measured Plasma Concentration (Cmax) of Total Mo
|
330 ng/mL
Standard Deviation 124
|
401 ng/mL
Standard Deviation 78.3
|
385 ng/mL
Standard Deviation 71.3
|
PRIMARY outcome
Timeframe: Day 1 through 14 days following final dose (up to Day 43)Population: All enrolled participants who received at least 1 dose of study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Treatment A: ALXN1840 (Fasted)
n=18 Participants
ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
|
Treatment B: Omeprazole + ALXN1840 (Fasted)
n=18 Participants
Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
|
Treatment C: Omeprazole + ALXN1840 (Fed)
n=18 Participants
Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
6 Participants
|
5 Participants
|
6 Participants
|
Adverse Events
Treatment A: ALXN1840 (Fasted)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment B: Omeprazole + ALXN1840 (Fasted)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment C: Omeprazole + ALXN1840 (Fed)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: ALXN1840 (Fasted)
n=18 participants at risk
ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
|
Treatment B: Omeprazole + ALXN1840 (Fasted)
n=18 participants at risk
Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
|
Treatment C: Omeprazole + ALXN1840 (Fed)
n=18 participants at risk
Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
|
|---|---|---|---|
|
Eye disorders
Eyelid oedema
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Superficial injury of eye
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
16.7%
3/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
3/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
|
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