Trial Outcomes & Findings for A Study of the Cardiac Effects of ALXN1840 in Healthy Adults (NCT NCT04560816)
NCT ID: NCT04560816
Last Updated: 2023-08-14
Results Overview
Twelve-lead electrocardiograms (ECGs) were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period. Change from baseline in the QT interval was corrected for heart rate using Fridericia's formula (ΔQTcF). ΔQTcF was based on a mixed-effects model for repeated measures (MMRM) with ΔQTcF as the dependent variable; period, sequence, time, treatment, and time-by-treatment interaction as fixed effects; and baseline QTc and sex as covariates. ΔΔQTc = LS mean ΔQTcF after ALXN1840 dosing minus LS mean ΔQTcF after placebo. If the upper bound of the confidence interval (CI) of ΔΔQTcF was \< 10 ms for all postdose time points, ALXN1840 was concluded to not have a significant effect on QT interval prolongation.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
Baseline (average of samples taken at -45, -30, and -15 minutes before dosing), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 (Day 2) hours postdose
Results posted on
2023-08-14
Participant Flow
Only healthy participants were eligible for enrollment. Participants with cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurologic disorders; abnormal blood pressure, history of cardiac abnormalities, or abnormal clinical laboratory results were excluded from the study.
One participant was excluded from the pharmacokinetic (PK)/corrected QT interval (QTc) set as a result of having no postdose data for PK concentration and QTc data at matching time points.
Participant milestones
| Measure |
Treatment Sequence 1: ABC
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: ALXN1840 120 milligrams (mg) administered as 15 mg enteric-coated tablets (supratherapeutic dose). Period 2: Enteric-coated placebo tablets matching ALXN1840. Period 3: Moxifloxacin 400 mg tablet.
|
Treatment Sequence 2: ACB
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose). Period 2: Moxifloxacin 400 mg tablet. Period 3: Enteric-coated placebo tablets matching ALXN1840.
|
Treatment Sequence 3: BAC
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: Enteric-coated placebo tablets matching ALXN1840. Period 2: ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose). Period 3: Moxifloxacin 400 mg tablet.
|
Treatment Sequence 4: BCA
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: Enteric-coated placebo tablets matching ALXN1840. Period 2: Moxifloxacin 400 mg tablet. Period 3: ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Treatment Sequence 5: CAB
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: Moxifloxacin 400 mg tablet. Period 2: ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose). Period 3: Enteric-coated placebo tablets matching ALXN1840.
|
Treatment Sequence 6: CBA
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: Moxifloxacin 400 mg tablet. Period 2: Enteric-coated placebo tablets matching ALXN1840. Period 3: ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
8
|
9
|
11
|
8
|
|
Overall Study
COMPLETED
|
8
|
9
|
7
|
9
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1: ABC
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: ALXN1840 120 milligrams (mg) administered as 15 mg enteric-coated tablets (supratherapeutic dose). Period 2: Enteric-coated placebo tablets matching ALXN1840. Period 3: Moxifloxacin 400 mg tablet.
|
Treatment Sequence 2: ACB
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose). Period 2: Moxifloxacin 400 mg tablet. Period 3: Enteric-coated placebo tablets matching ALXN1840.
|
Treatment Sequence 3: BAC
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: Enteric-coated placebo tablets matching ALXN1840. Period 2: ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose). Period 3: Moxifloxacin 400 mg tablet.
|
Treatment Sequence 4: BCA
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: Enteric-coated placebo tablets matching ALXN1840. Period 2: Moxifloxacin 400 mg tablet. Period 3: ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Treatment Sequence 5: CAB
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: Moxifloxacin 400 mg tablet. Period 2: ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose). Period 3: Enteric-coated placebo tablets matching ALXN1840.
|
Treatment Sequence 6: CBA
On Day 1 of each period, participants received a single dose of the following study interventions:
Period 1: Moxifloxacin 400 mg tablet. Period 2: Enteric-coated placebo tablets matching ALXN1840. Period 3: ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of the Cardiac Effects of ALXN1840 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Overall Study
n=57 Participants
All participants were randomly assigned to receive a single dose of each the following 3 treatments in 1 of 6 treatment sequences:
* ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose)
* Enteric-coated placebo tablets matching ALXN1840
* Moxifloxacin 400 mg tablet
|
|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 7.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (average of samples taken at -45, -30, and -15 minutes before dosing), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 (Day 2) hours postdosePopulation: All participants who received at least 1 dose of study treatment with measurements at baseline as well as on-treatment with evaluable data at the specified timepoints.
Twelve-lead electrocardiograms (ECGs) were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period. Change from baseline in the QT interval was corrected for heart rate using Fridericia's formula (ΔQTcF). ΔQTcF was based on a mixed-effects model for repeated measures (MMRM) with ΔQTcF as the dependent variable; period, sequence, time, treatment, and time-by-treatment interaction as fixed effects; and baseline QTc and sex as covariates. ΔΔQTc = LS mean ΔQTcF after ALXN1840 dosing minus LS mean ΔQTcF after placebo. If the upper bound of the confidence interval (CI) of ΔΔQTcF was \< 10 ms for all postdose time points, ALXN1840 was concluded to not have a significant effect on QT interval prolongation.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 0.5 hours postdose
|
-0.21 ms
Interval -1.46 to 1.05
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 1 hour postdose
|
-0.31 ms
Interval -1.64 to 1.02
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 2 hours postdose
|
0.07 ms
Interval -1.43 to 1.57
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 3 hours postdose
|
-0.64 ms
Interval -2.06 to 0.79
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 4 hours postdose
|
-1.08 ms
Interval -2.75 to 0.59
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 5 hours postdose
|
-0.90 ms
Interval -1.8 to 1.6
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 6 hours postdose
|
-0.71 ms
Interval -2.72 to 1.31
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 7 hours postdose
|
0.25 ms
Interval -1.56 to 2.06
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 8 hours postdose
|
-0.93 ms
Interval -2.56 to 0.69
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 10 hours postdose
|
0.76 ms
Interval -1.15 to 2.67
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 1, 12 hours postdose
|
0.05 ms
Interval -2.14 to 2.23
|
—
|
—
|
|
Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis
Day 2, 24 hours postdose
|
2.30 ms
Interval 0.85 to 3.74
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 2, and 3 hours postdose at Day 1Population: All participants who received at least 1 dose of moxifloxacin with measurements at baseline as well as on-treatment with evaluable data at the specified timepoints.
Assay sensitivity was evaluated using the by-time point analysis of the effect on ΔΔQTc of moxifloxacin. If ΔΔQTcF was larger than 5 ms at 1, 2, and 3 hours postdose, assay sensitivity was considered to be demonstrated.
Outcome measures
| Measure |
ALXN1840
n=53 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
ΔΔQTcF For Moxifloxacin Using The By-time Point Analysis
Day 1, 1 hour postdose
|
9.65 ms
Interval 8.29 to 11.01
|
—
|
—
|
|
ΔΔQTcF For Moxifloxacin Using The By-time Point Analysis
Day 1, 2 hours postdose
|
11.04 ms
Interval 9.51 to 12.57
|
—
|
—
|
|
ΔΔQTcF For Moxifloxacin Using The By-time Point Analysis
Day 1, 3 hours postdose
|
11.37 ms
Interval 9.91 to 12.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (average of samples taken at 45, -30, and -15 minutes before dosing), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 (Day 2) hours postdosePopulation: All participants who received at least 1 dose of study treatment with measurements at baseline as well as on-treatment with evaluable data at the specified timepoints.
Twelve-lead ECGs were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
n=56 Participants
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
n=53 Participants
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 5 hours postdose
|
5.85 bpm
Interval 4.81 to 6.9
|
4.83 bpm
Interval 3.78 to 5.87
|
5.82 bpm
Interval 4.74 to 6.9
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 6 hours postdose
|
7.07 bpm
Interval 5.98 to 8.17
|
6.95 bpm
Interval 5.86 to 8.03
|
7.43 bpm
Interval 6.3 to 8.56
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 7 hours postdose
|
5.59 bpm
Interval 4.31 to 6.87
|
4.32 bpm
Interval 3.03 to 5.61
|
6.61 bpm
Interval 5.26 to 7.95
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 8 hours postdose
|
4.69 bpm
Interval 3.61 to 5.77
|
3.97 bpm
Interval 2.89 to 5.05
|
5.37 bpm
Interval 4.25 to 6.49
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 10 hours postdose
|
7.71 bpm
Interval 6.38 to 9.04
|
7.44 bpm
Interval 6.09 to 8.79
|
9.15 bpm
Interval 7.76 to 10.54
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 12 hours postdose
|
5.76 bpm
Interval 4.55 to 6.97
|
5.18 bpm
Interval 3.93 to 6.43
|
6.93 bpm
Interval 5.68 to 8.19
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 2, 24 hours postdose
|
2.32 bpm
Interval 1.25 to 3.4
|
1.60 bpm
Interval 0.53 to 2.67
|
2.92 bpm
Interval 1.81 to 4.02
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 0.5 hours postdose
|
-0.27 bpm
Interval -1.06 to 0.52
|
0.50 bpm
Interval -0.29 to 1.3
|
1.27 bpm
Interval 0.45 to 2.09
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 1 hour postdose
|
-0.02 bpm
Interval -0.9 to 0.85
|
0.38 bpm
Interval -0.5 to 1.26
|
3.87 bpm
Interval 2.97 to 4.78
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 2 hours postdose
|
-0.12 bpm
Interval -0.93 to 0.69
|
0.19 bpm
Interval -0.61 to 1.0
|
1.97 bpm
Interval 1.15 to 2.8
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 3 hours postdose
|
0.41 bpm
Interval -0.53 to 1.35
|
-1.17 bpm
Interval -2.11 to -0.22
|
2.14 bpm
Interval 1.17 to 3.12
|
|
Change From Baseline For Heart Rate (ΔHR)
Day 1, 4 hours postdose
|
0.51 bpm
Interval -0.5 to 1.52
|
0.24 bpm
Interval -0.77 to 1.25
|
2.30 bpm
Interval 1.26 to 3.35
|
SECONDARY outcome
Timeframe: Baseline (average of samples taken at 45, -30, and -15 minutes before dosing), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 (Day 2) hours postdosePopulation: All participants who received at least 1 dose of study treatment with measurements at baseline as well as on-treatment with evaluable data at the specified timepoints.
Twelve-lead ECGs were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
n=56 Participants
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
n=53 Participants
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 5 hours postdose
|
-0.64 ms
Interval -1.89 to 0.61
|
-0.55 ms
Interval -1.8 to 0.71
|
9.54 ms
Interval 8.24 to 10.83
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 0.5 hours postdose
|
-2.56 ms
Interval -3.52 to -1.61
|
-2.36 ms
Interval -3.31 to -1.4
|
2.29 ms
Interval 1.3 to 3.27
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 1 hour postdose
|
-0.49 ms
Interval -1.49 to 0.51
|
-0.19 ms
Interval -1.19 to 0.82
|
9.47 ms
Interval 8.43 to 10.5
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 2 hours postdose
|
-0.69 ms
Interval -1.81 to 0.43
|
-0.76 ms
Interval -1.88 to 0.35
|
10.28 ms
Interval 9.12 to 11.43
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 3 hours postdose
|
-1.04 ms
Interval -2.11 to 0.02
|
-0.41 ms
Interval -1.47 to 0.66
|
10.96 ms
Interval 9.86 to 12.07
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 4 hours postdose
|
-1.06 ms
Interval -2.29 to 0.16
|
0.02 ms
Interval -1.21 to 1.25
|
10.03 ms
Interval 8.75 to 11.3
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 6 hours postdose
|
-6.05 ms
Interval -7.52 to -4.58
|
-5.35 ms
Interval -6.8 to -3.89
|
4.00 ms
Interval 2.48 to 5.53
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 7 hours postdose
|
-7.60 ms
Interval -8.92 to -6.28
|
-7.85 ms
Interval -9.18 to -6.52
|
2.05 ms
Interval 0.67 to 3.43
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 8 hours postdose
|
-7.66 ms
Interval -8.86 to -6.47
|
-6.73 ms
Interval -7.93 to -5.53
|
1.49 ms
Interval 0.25 to 2.73
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 10 hours postdose
|
-4.96 ms
Interval -6.34 to -3.58
|
-5.73 ms
Interval -7.13 to -4.33
|
1.70 ms
Interval 0.25 to 3.15
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 1, 12 hours postdose
|
-5.05 ms
Interval -6.61 to -3.49
|
-5.10 ms
Interval -6.7 to -3.5
|
0.94 ms
Interval -0.68 to 2.56
|
|
Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)
Day 2, 24 hours postdose
|
0.52 ms
Interval -0.56 to 1.6
|
-1.78 ms
Interval -2.85 to -0.7
|
3.48 ms
Interval 2.37 to 4.59
|
SECONDARY outcome
Timeframe: Baseline (average of samples taken at 45, -30, and -15 minutes before dosing), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 (Day 2) hours postdosePopulation: All participants who received at least 1 dose of study treatment with measurements at baseline as well as on-treatment with evaluable data at the specified timepoints.
Twelve-lead ECGs were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
n=56 Participants
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
n=53 Participants
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 0.5 hours postdose
|
-0.13 ms
Interval -1.55 to 1.29
|
1.26 ms
Interval -0.16 to 2.69
|
-1.33 ms
Interval -2.81 to 0.14
|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 1 hour postdose
|
0.41 ms
Interval -0.95 to 1.78
|
1.66 ms
Interval 0.29 to 3.03
|
-1.37 ms
Interval -2.79 to 0.04
|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 2 hours postdose
|
1.30 ms
Interval 0.05 to 2.56
|
1.54 ms
Interval 0.29 to 2.79
|
-0.77 ms
Interval -2.06 to 0.52
|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 3 hours postdose
|
0.46 ms
Interval -0.88 to 1.79
|
1.32 ms
Interval -0.01 to 2.66
|
-2.66 ms
Interval -4.05 to -1.28
|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 4 hours postdose
|
-0.75 ms
Interval -2.08 to 0.58
|
-0.10 ms
Interval -1.43 to 1.23
|
-3.38 ms
Interval -4.75 to -2.0
|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 5 hours postdose
|
-1.72 ms
Interval -3.14 to -0.3
|
-1.12 ms
Interval -2.54 to 0.31
|
-4.22 ms
Interval -5.7 to -2.75
|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 6 hours postdose
|
-3.64 ms
Interval -5.0 to -2.28
|
-3.43 ms
Interval -4.79 to -2.08
|
-5.52 ms
Interval -6.93 to -4.11
|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 8 hours postdose
|
-4.52 ms
Interval -5.86 to -3.18
|
-3.83 ms
Interval -5.17 to -2.48
|
-7.07 ms
Interval -8.46 to -5.68
|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 10 hours postdose
|
-3.94 ms
Interval -5.57 to -2.32
|
-3.34 ms
Interval -4.97 to -1.69
|
-6.61 ms
Interval -8.3 to -4.91
|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 12 hours postdose
|
-2.89 ms
Interval -4.21 to -1.56
|
-2.98 ms
Interval -4.35 to -1.61
|
-4.60 ms
Interval -5.98 to -3.22
|
|
Change From Baseline PR Interval (ΔPR)
Day 2, 24 hours postdose
|
-0.13 ms
Interval -1.55 to 1.29
|
0.69 ms
Interval -0.73 to 2.1
|
-1.68 ms
Interval -3.14 to -0.21
|
|
Change From Baseline PR Interval (ΔPR)
Day 1, 7 hours postdose
|
-5.76 ms
Interval -7.14 to -4.38
|
-4.05 ms
Interval -5.44 to -2.67
|
-7.16 ms
Interval -8.59 to -5.72
|
SECONDARY outcome
Timeframe: Baseline (average of samples taken at 45, -30, and -15 minutes before dosing), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 (Day 2) hours postdosePopulation: All participants who received at least 1 dose of study treatment with measurements at baseline as well as on-treatment with evaluable data at the specified timepoints.
Twelve-lead ECGs were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
n=56 Participants
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
n=53 Participants
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 1 hour postdose
|
0.04 ms
Interval -0.2 to 0.29
|
-0.04 ms
Interval -0.29 to 0.21
|
0.06 ms
Interval -0.19 to 0.32
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 2 hours postdose
|
0.08 ms
Interval -0.2 to 0.36
|
-0.09 ms
Interval -0.38 to 0.19
|
-0.10 ms
Interval -0.39 to 0.19
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 0.5 hours postdose
|
-0.01 ms
Interval -0.22 to 0.21
|
-0.07 ms
Interval -0.29 to 0.14
|
-0.08 ms
Interval -0.3 to 0.14
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 3 hours postdose
|
0.10 ms
Interval -0.17 to 0.38
|
-0.05 ms
Interval -0.33 to 0.22
|
-0.19 ms
Interval -0.47 to 0.1
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 4 hours postdose
|
0.14 ms
Interval -0.14 to 0.43
|
0.16 ms
Interval -0.13 to 0.44
|
0.01 ms
Interval -0.29 to 0.3
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 5 hours postdose
|
-0.23 ms
Interval -0.54 to 0.09
|
-0.28 ms
Interval -0.6 to 0.04
|
-0.35 ms
Interval -0.68 to -0.02
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 6 hours postdose
|
-1.01 ms
Interval -1.31 to -0.71
|
-0.73 ms
Interval -1.03 to -0.44
|
-1.13 ms
Interval -1.44 to -0.82
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 7 hours postdose
|
-0.89 ms
Interval -1.16 to -0.63
|
-1.08 ms
Interval -1.34 to -0.82
|
-1.16 ms
Interval -1.44 to -0.89
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 8 hours postdose
|
-0.66 ms
Interval -0.97 to -0.35
|
-0.39 ms
Interval -0.69 to -0.08
|
-0.48 ms
Interval -0.8 to -0.16
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 10 hours postdose
|
-0.89 ms
Interval -1.26 to -0.52
|
-0.71 ms
Interval -1.08 to -0.34
|
-0.87 ms
Interval -1.25 to -0.48
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 1, 12 hours postdose
|
-0.42 ms
Interval -0.74 to 0.11
|
-0.30 ms
Interval -0.62 to 0.02
|
-0.50 ms
Interval -0.83 to -0.18
|
|
Change From Baseline QRS Interval (ΔQRS)
Day 2, 24 hours postdose
|
-0.14 ms
Interval -0.44 to 0.16
|
0.02 ms
Interval -0.27 to 0.32
|
-0.18 ms
Interval -0.48 to 0.13
|
SECONDARY outcome
Timeframe: Baseline (average of samples taken at 45, -30, and -15 minutes before dosing), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 (Day 2) hours postdosePopulation: All participants who received at least 1 dose of study treatment with measurements at baseline as well as on-treatment with evaluable data at the specified timepoints.
Twelve-lead ECGs were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period. Least square mean difference and its 90% CI were calculated based on MMRM with fixed effects for period, sequence, timepoint, treatment, time-by-treatment interaction as fixed effect and baseline value and sex as covariates.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
n=53 Participants
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 0.5 hours postdose
|
-0.77 bpm
Interval -1.76 to 0.21
|
0.77 bpm
Interval -0.24 to 1.77
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 1 hour postdose
|
-0.40 bpm
Interval -1.52 to 0.72
|
3.50 bpm
Interval 2.35 to 4.64
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 2 hours postdose
|
-0.31 bpm
Interval -1.32 to 0.69
|
1.78 bpm
Interval 0.76 to 2.8
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 3 hours postdose
|
1.58 bpm
Interval 0.36 to 2.8
|
3.31 bpm
Interval 2.07 to 4.56
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 4 hours postdose
|
0.27 bpm
Interval -1.06 to 1.59
|
2.06 bpm
Interval 0.71 to 3.42
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 5 hours postdose
|
1.02 bpm
Interval -0.35 to 2.4
|
0.99 bpm
Interval -0.41 to 2.4
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 6 hours postdose
|
0.13 bpm
Interval -1.32 to 1.58
|
0.48 bpm
Interval -0.99 to 1.96
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 7 hours postdose
|
1.27 bpm
Interval -0.47 to 3.0
|
2.29 bpm
Interval 0.5 to 4.07
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 8 hours postdose
|
0.72 bpm
Interval -0.72 to 2.15
|
1.40 bpm
Interval -0.07 to 2.86
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 10 hours postdose
|
0.27 bpm
Interval -1.54 to 2.09
|
1.71 bpm
Interval -0.15 to 3.58
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 1, 12 hours postdose
|
0.58 bpm
Interval -1.07 to 2.24
|
1.75 bpm
Interval 0.06 to 3.45
|
—
|
|
Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)
Day 2, 24 hours postdose
|
0.73 bpm
Interval -0.69 to 2.15
|
1.32 bpm
Interval -0.12 to 2.76
|
—
|
SECONDARY outcome
Timeframe: Baseline (average of samples taken at 45, -30, and -15 minutes before dosing), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 (Day 2) hours postdosePopulation: All participants who received at least 1 dose of study treatment with measurements at baseline as well as on-treatment with evaluable data at the specified timepoints.
Twelve-lead ECGs were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
n=53 Participants
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 0.5 hours postdose
|
-1.39 ms
Interval -3.29 to 0.51
|
-2.60 ms
Interval -4.54 to -0.66
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 1 hour postdose
|
-1.25 ms
Interval -3.07 to 0.57
|
-3.03 ms
Interval -4.89 to -1.18
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 2 hours postdose
|
-0.24 ms
Interval -1.88 to 1.41
|
-2.31 ms
Interval -3.98 to -0.63
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 3 hours postdose
|
-0.87 ms
Interval -2.64 to 0.9
|
-3.99 ms
Interval -5.79 to -2.18
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 4 hours postdose
|
-0.65 ms
Interval -2.41 to 1.11
|
-3.28 ms
Interval -5.08 to -1.48
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 5 hours postdose
|
-0.60 ms
Interval -2.51 to 1.3
|
-3.11 ms
Interval -5.05 to -1.16
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 6 hours postdose
|
-0.21 ms
Interval -2.01 to 1.6
|
-2.09 ms
Interval -3.93 to -0.24
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 7 hours postdose
|
-1.71 ms
Interval -3.55 to 0.14
|
-3.10 ms
Interval -4.99 to -1.21
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 8 hours postdose
|
-0.69 ms
Interval -2.48 to 1.09
|
-3.24 ms
Interval -5.06 to -1.42
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 10 hours postdose
|
-0.61 ms
Interval -2.83 to 1.6
|
-3.28 ms
Interval -5.54 to -1.01
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 1, 12 hours postdose
|
0.09 ms
Interval -1.7 to 1.89
|
-1.62 ms
Interval -3.46 to 0.21
|
—
|
|
Placebo-corrected Change From Baseline PR Interval (ΔΔPR)
Day 2, 24 hours postdose
|
-0.82 ms
Interval -2.71 to 1.08
|
-2.37 ms
Interval -4.3 to -0.44
|
—
|
SECONDARY outcome
Timeframe: Baseline (average of samples taken at 45, -30, and -15 minutes before dosing), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 (Day 2) hours postdosePopulation: All participants who received at least 1 dose of study treatment with measurements at baseline as well as on-treatment with evaluable data at the specified timepoints.
Twelve-lead ECGs were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period. Least square mean difference and its 90% CI were calculated based on MMRM with fixed effects for period, sequence, timepoint, treatment, time-by-treatment interaction as fixed effect and baseline value and sex as covariates.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
n=53 Participants
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 0.5 hours postdose
|
0.07 ms
Interval -0.21 to 0.35
|
-0.01 ms
Interval -0.29 to 0.28
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 1 hour postdose
|
0.08 ms
Interval -0.25 to 0.41
|
0.10 ms
Interval -0.23 to 0.44
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 2 hours postdose
|
0.17 ms
Interval -0.21 to 0.56
|
-0.01 ms
Interval -0.4 to 0.38
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 3 hours postdose
|
0.15 ms
Interval -0.22 to 0.53
|
-0.13 ms
Interval -0.52 to 0.25
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 4 hours postdose
|
-0.02 ms
Interval -0.4 to 0.37
|
-0.15 ms
Interval -0.55 to 0.24
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 5 hours postdose
|
0.05 ms
Interval -0.38 to 0.49
|
-0.07 ms
Interval -0.51 to 0.38
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 6 hours postdose
|
-0.27 ms
Interval -0.68 to 0.13
|
-0.40 ms
Interval -0.81 to 0.01
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 7 hours postdose
|
0.19 ms
Interval -0.17 to 0.54
|
-0.08 ms
Interval -0.45 to 0.28
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 8 hours postdose
|
-0.27 ms
Interval -0.69 to 0.15
|
-0.10 ms
Interval -0.52 to 0.33
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 10 hours postdose
|
-0.18 ms
Interval -0.69 to 0.33
|
-0.15 ms
Interval -0.68 to 0.37
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 1, 12 hours postdose
|
-0.12 ms
Interval -0.56 to 0.31
|
-0.20 ms
Interval -0.65 to 0.24
|
—
|
|
Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)
Day 2, 24 hours postdose
|
-0.16 ms
Interval -0.57 to 0.25
|
-0.20 ms
Interval -0.61 to 0.21
|
—
|
SECONDARY outcome
Timeframe: Day 1 (after dosing) through 24 hours postdosePopulation: All participants who received at least 1 dose of study treatment with measurements at baseline as well as on-treatment with at least 1 postdose time point.
Twelve-lead ECGs were extracted from approximately 25-hour continuous (Holter) recordings on Day -1 of Treatment Period 1 and Days 1 and 2 in each treatment period.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
n=56 Participants
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
n=53 Participants
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent T-wave Morphology Abnormalities and U-waves
At least one treatment-emergent T-wave abnormality
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent T-wave Morphology Abnormalities and U-waves
At least one treatment-emergent U-wave
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose (0) to 96 hours post-dosePopulation: All participants who received at least 1 dose of study treatment with evaluable data. It was pre-specified to collect data for only the ALXN1840 Arm for this outcome measure.
Blood samples for PK analysis of total molybdenum and PUF molybdenum were collected as close as possible to nominal time after completion of the ECG extraction period.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
ALXN1840 PK Parameter: Area Under The Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUC0-t) Of Total Molybdenum And Plasma Ultrafiltrate (PUF) Molybdenum Following a Single Oral Dose of ALXN1840
Total Molybdenum
|
18450 h*ng/mL
Geometric Coefficient of Variation 44.5
|
—
|
—
|
|
ALXN1840 PK Parameter: Area Under The Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUC0-t) Of Total Molybdenum And Plasma Ultrafiltrate (PUF) Molybdenum Following a Single Oral Dose of ALXN1840
Plasma Ultrafiltrate Molybdenum
|
1763 h*ng/mL
Geometric Coefficient of Variation 84.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0) to 96 hours post-dosePopulation: All participants who received at least 1 dose of study treatment with evaluable data. It was pre-specified to collect data for only the ALXN1840 Arm for this outcome measure.
Blood samples for PK analysis of total molybdenum and PUF molybdenum were collected as close as possible to nominal time after completion of the ECG extraction period.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
ALXN1840 PK Parameter: Maximum Observed Concentration (Cmax) Of Total Molybdenum And PUF Molybdenum Following a Single Oral Dose of ALXN1840
Total Molybdenum
|
504.1 ng/mL
Geometric Coefficient of Variation 46.8
|
—
|
—
|
|
ALXN1840 PK Parameter: Maximum Observed Concentration (Cmax) Of Total Molybdenum And PUF Molybdenum Following a Single Oral Dose of ALXN1840
Plasma Ultrafiltrate Molybdenum
|
127.9 ng/mL
Geometric Coefficient of Variation 120.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose to 96 hours post-dosePopulation: All participants who received at least 1 dose of study treatment with evaluable data. It was pre-specified to collect data for only the ALXN1840 Arm for this outcome measure.
Blood samples for PK analysis of total molybdenum and PUF molybdenum were collected as close as possible to nominal time after completion of the ECG extraction period.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
ALXN1840 PK Parameter: Time To Maximum Observed Concentration (Tmax) Of Total Molybdenum And PUF Molybdenum Following a Single Oral Dose of ALXN1840
Total Molybdenum
|
5.00 hours
Interval 0.52 to 8.02
|
—
|
—
|
|
ALXN1840 PK Parameter: Time To Maximum Observed Concentration (Tmax) Of Total Molybdenum And PUF Molybdenum Following a Single Oral Dose of ALXN1840
Plasma Ultrafiltrate Molybdenum
|
6.00 hours
Interval 3.0 to 10.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (after dosing) through Day 70Population: All participants who received at least 1 dose of study drug.
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was an AE that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose. A related TEAE was defined as having a reasonable possibility the study intervention caused the AE as assessed by the investigator. Serious AEs were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event.
Outcome measures
| Measure |
ALXN1840
n=57 Participants
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
n=56 Participants
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
n=53 Participants
Participants received moxifloxacin 400 mg tablet.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
9 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any serious TEAE (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any related TEAE
|
4 Participants
|
0 Participants
|
3 Participants
|
Adverse Events
ALXN1840
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Moxifloxacin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Overall
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ALXN1840
n=57 participants at risk
Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose).
|
Placebo
n=56 participants at risk
Participants received enteric-coated placebo tablets matching ALXN1840.
|
Moxifloxacin
n=53 participants at risk
Participants received moxifloxacin 400 mg tablet.
|
Overall
n=57 participants at risk
All treated participants.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
1.9%
1/53 • Number of events 1 • Day 1 (after dosing) through Day 70
|
3.5%
2/57 • Number of events 2 • Day 1 (after dosing) through Day 70
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
1.8%
1/56 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
1.8%
1/56 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
1.9%
1/53 • Number of events 1 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
5.7%
3/53 • Number of events 3 • Day 1 (after dosing) through Day 70
|
7.0%
4/57 • Number of events 4 • Day 1 (after dosing) through Day 70
|
|
Gastrointestinal disorders
Proctalgia
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
General disorders
Fatigue
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
1.9%
1/53 • Number of events 1 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
General disorders
Feeling cold
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
1.9%
1/53 • Number of events 1 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Infections and infestations
Hordeolum
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Infections and infestations
Pustule
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
1.9%
1/53 • Number of events 1 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
1.8%
1/56 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Injury, poisoning and procedural complications
Chemical burns of eye
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
1.9%
1/53 • Number of events 1 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Investigations
SARS-CoV-2 test positive
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
1.9%
1/53 • Number of events 1 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
1.8%
1/56 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Nervous system disorders
Dizziness
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
3.8%
2/53 • Number of events 2 • Day 1 (after dosing) through Day 70
|
5.3%
3/57 • Number of events 3 • Day 1 (after dosing) through Day 70
|
|
Nervous system disorders
Headache
|
3.5%
2/57 • Number of events 2 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
3.5%
2/57 • Number of events 2 • Day 1 (after dosing) through Day 70
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
0.00%
0/53 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/57 • Day 1 (after dosing) through Day 70
|
0.00%
0/56 • Day 1 (after dosing) through Day 70
|
1.9%
1/53 • Number of events 1 • Day 1 (after dosing) through Day 70
|
1.8%
1/57 • Number of events 1 • Day 1 (after dosing) through Day 70
|
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place