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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
| ERT: Clinical Trial Technology Solutions | OTHER |
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This study will evaluate the effect of a supratherapeutic dose of ALXN1840 on the heart rate (HR)-corrected QT interval (QTc) in healthy adult participants. Moxifloxacin will be used as the active control.
This is a randomized, 3-treatment, 3-period, 6-sequence, crossover, placebo- and active-controlled, double-blind for ALXN1840, open-label for moxifloxacin, in healthy adult participants. Participants will be domiciled in the clinic for 7 days during Treatment Period 1 and for 6 days during Treatment Period 2 and 3. A single oral dose of each treatment (ALXN1840, matching ALXN1840 placebo, or moxifloxacin) will be administered on Day 1 of each period following an overnight fast of at least 10 hours. There will be a minimum 14-day washout between study intervention administrations for each treatment period. Cardiodynamic, pharmacokinetic, and safety assessments will be performed at certain times during the study. An end-of-study visit will occur 14 days (±2 days) after the last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | On Day 1 of each period, participants will receive a single dose of the following study interventions: Period 1: ALXN1840. Period 2: Placebo-matching ALXN1840. Period 3: Moxifloxacin. |
|
| Treatment Sequence 2 | Experimental | On Day 1 of each period, participants will receive a single dose of the following study interventions: Period 1: ALXN1840. Period 2: Moxifloxacin. Period 3: Placebo-matching ALXN1840. |
|
| Treatment Sequence 3 | Experimental | On Day 1 of each period, participants will receive a single dose of the following study interventions: Period 1: Placebo-matching ALXN1840. Period 2: ALXN1840. Period 3: Moxifloxacin. |
|
| Treatment Sequence 4 | Experimental | On Day 1 of each period, participants will receive a single dose of the following study interventions: Period 1: Placebo-matching ALXN1840. Period 2: Moxifloxacin. Period 3: ALXN1840. |
|
| Treatment Sequence 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1840 | Drug | ALXN1840 (120 milligrams) will be administered orally (supratherapeutic dose). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ΔΔQTcF For Moxifloxacin Using The By-time Point Analysis | 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. | 1, 2, and 3 hours postdose at Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene S. Swenson, MD, PhD | Alexion Pharmaceuticals, Inc. | Study Director |
| Masood Sadaat, MD, MSc | Alexion Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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). |
| FG004 | 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. |
| FG005 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of ALXN1840 during treatment period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All participants were randomly assigned to receive a single dose of each the following 3 treatments in 1 of 6 treatment sequences:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | ms | 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 |
Day 1 (after dosing) through Day 70
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALXN1840 | Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | 855-752-2356 | clinicaltrials@alexion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2020 | Mar 25, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2020 | Mar 25, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006527 | Hepatolenticular Degeneration |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C020809 | tetrathiomolybdate |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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This will be a 3-treatment, 3-period, 6-sequence, crossover study in healthy adults.
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This study will employ a double-blind study design. The ALXN1840 and matching placebo will be identical in appearance and will be administered in a double-blind manner.
Moxifloxacin will not be blinded.
On Day 1 of each period, participants will receive a single dose of the following study interventions: Period 1: Moxifloxacin. Period 2: ALXN1840. Period 3: Placebo-matching ALXN1840. |
|
| Treatment Sequence 6 | Experimental | On Day 1 of each period, participants will receive a single dose of the following study interventions: Period 1: Moxifloxacin. Period 2: Placebo-matching ALXN1840. Period 3: ALXN1840. |
|
|
| Placebo | Drug | Placebo will be administered orally. |
|
|
| Moxifloxacin | Drug | Moxifloxacin (400 milligrams) will be administered orally. |
|
| Change From Baseline For Heart Rate (ΔHR) |
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. |
| 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 |
| Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF) | 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. | 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 |
| Change From Baseline PR Interval (ΔPR) | 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. | 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 |
| Change From Baseline QRS Interval (ΔQRS) | 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. | 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 |
| Placebo-corrected Change From Baseline Heart Rate (ΔΔHR) | 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. | 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 |
| Placebo-corrected Change From Baseline PR Interval (ΔΔPR) | 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. | 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 |
| Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS) | 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. | 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 |
| Number of Participants With Treatment-emergent T-wave Morphology Abnormalities and U-waves | 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. | Day 1 (after dosing) through 24 hours postdose |
| 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 | 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. | Predose (0) to 96 hours post-dose |
| ALXN1840 PK Parameter: Maximum Observed Concentration (Cmax) Of Total Molybdenum And PUF Molybdenum Following a Single Oral Dose of ALXN1840 | 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. | Predose (0) to 96 hours post-dose |
| ALXN1840 PK Parameter: Time To Maximum Observed Concentration (Tmax) Of Total Molybdenum And PUF Molybdenum Following a Single Oral Dose of ALXN1840 | 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. | Pre-dose to 96 hours post-dose |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | Day 1 (after dosing) through Day 70 |
| Lost to Follow-up |
|
| Protocol Violation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | ALXN1840 | Participants received ALXN1840 120 mg administered as 15 mg enteric-coated tablets (supratherapeutic dose). |
|
|
| Secondary | ΔΔQTcF For Moxifloxacin Using The By-time Point Analysis | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | ms | 1, 2, and 3 hours postdose at Day 1 |
|
|
|
| Secondary | Change From Baseline For Heart Rate (ΔHR) | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | bpm | 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 |
|
|
|
| Secondary | Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF) | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | ms | 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 |
|
|
|
| Secondary | Change From Baseline PR Interval (ΔPR) | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | ms | 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 |
|
|
|
| Secondary | Change From Baseline QRS Interval (ΔQRS) | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | ms | 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 |
|
|
|
| Secondary | Placebo-corrected Change From Baseline Heart Rate (ΔΔHR) | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | bpm | 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 |
|
|
|
| Secondary | Placebo-corrected Change From Baseline PR Interval (ΔΔPR) | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | ms | 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 |
|
|
|
| Secondary | Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS) | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | ms | 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 |
|
|
|
| Secondary | Number of Participants With Treatment-emergent T-wave Morphology Abnormalities and U-waves | 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. | 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. | Posted | Count of Participants | Participants | Day 1 (after dosing) through 24 hours postdose |
|
|
|
| Secondary | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose (0) to 96 hours post-dose |
|
|
|
| Secondary | ALXN1840 PK Parameter: Maximum Observed Concentration (Cmax) Of Total Molybdenum And PUF Molybdenum Following a Single Oral Dose of ALXN1840 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose (0) to 96 hours post-dose |
|
|
|
| Secondary | ALXN1840 PK Parameter: Time To Maximum Observed Concentration (Tmax) Of Total Molybdenum And PUF Molybdenum Following a Single Oral Dose of ALXN1840 | 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. | 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. | Posted | Median | Full Range | hours | Pre-dose to 96 hours post-dose |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 (after dosing) through Day 70 |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 9 |
| 57 |
| EG001 | Placebo | Participants received enteric-coated placebo tablets matching ALXN1840. | 0 | 56 | 0 | 56 | 3 | 56 |
| EG002 | Moxifloxacin | Participants received moxifloxacin 400 mg tablet. | 0 | 53 | 0 | 53 | 6 | 53 |
| EG003 | Overall | All treated participants. | 0 | 57 | 0 | 57 | 16 | 57 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Feeling of body temperature change | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Pustule | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Chemical burns of eye | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
Not provided
Not provided
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008661 | Metabolism, Inborn Errors |
| D008664 | Metal Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Day 1, 2 hours postdose |
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| Day 1, 3 hours postdose |
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| Day 1, 4 hours postdose |
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| Day 1, 5 hours postdose |
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| Day 1, 6 hours postdose |
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| Day 1, 7 hours postdose |
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| Day 1, 8 hours postdose |
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| Day 1, 10 hours postdose |
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| Day 1, 12 hours postdose |
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| Day 2, 24 hours postdose |
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| Day 1, 2 hours postdose |
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| Day 1, 3 hours postdose |
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| Day 1, 4 hours postdose |
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| Day 1, 5 hours postdose |
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| Day 1, 6 hours postdose |
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| Day 1, 7 hours postdose |
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| Day 1, 8 hours postdose |
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| Day 1, 10 hours postdose |
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| Day 1, 12 hours postdose |
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| Day 2, 24 hours postdose |
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| Day 1, 2 hours postdose |
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| Day 1, 3 hours postdose |
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| Day 1, 4 hours postdose |
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| Day 1, 5 hours postdose |
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| Day 1, 6 hours postdose |
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| Day 1, 7 hours postdose |
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| Day 1, 8 hours postdose |
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| Day 1, 10 hours postdose |
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| Day 1, 12 hours postdose |
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| Day 2, 24 hours postdose |
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| Day 1, 2 hours postdose |
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| Day 1, 3 hours postdose |
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| Day 1, 4 hours postdose |
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| Day 1, 5 hours postdose |
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| Day 1, 6 hours postdose |
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| Day 1, 7 hours postdose |
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| Day 1, 8 hours postdose |
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| Day 1, 10 hours postdose |
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| Day 1, 12 hours postdose |
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| Day 2, 24 hours postdose |
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| Day 1, 2 hours postdose |
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| Day 1, 3 hours postdose |
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| Day 1, 4 hours postdose |
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| Day 1, 5 hours postdose |
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| Day 1, 6 hours postdose |
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| Day 1, 7 hours postdose |
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| Day 1, 8 hours postdose |
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| Day 1, 10 hours postdose |
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| Day 1, 12 hours postdose |
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| Day 2, 24 hours postdose |
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| Day 1, 2 hours postdose |
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| Day 1, 3 hours postdose |
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| Day 1, 4 hours postdose |
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| Day 1, 5 hours postdose |
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| Day 1, 6 hours postdose |
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| Day 1, 7 hours postdose |
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| Day 1, 8 hours postdose |
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| Day 1, 10 hours postdose |
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| Day 1, 12 hours postdose |
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| Day 2, 24 hours postdose |
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| Day 1, 2 hours postdose |
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| Day 1, 3 hours postdose |
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| Day 1, 4 hours postdose |
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| Day 1, 5 hours postdose |
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| Day 1, 6 hours postdose |
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| Day 1, 7 hours postdose |
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| Day 1, 8 hours postdose |
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| Day 1, 10 hours postdose |
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| Day 1, 12 hours postdose |
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| Day 2, 24 hours postdose |
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| Title | Measurements |
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| Any TEAE leading to death |
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| Any related TEAE |
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