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| ID | Type | Description | Link |
|---|---|---|---|
| CA12887 | Other Identifier | Celerion |
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This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Molybdenum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: ABC | Experimental | Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 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. |
|
| Sequence 2: ACB | Experimental | Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing. |
|
| Sequence 3: BAC | Experimental | Participants received each treatment on 1 occasion: Period 1 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1840 | Drug | ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo) | AUC0-t was calculated by the linear trapezoidal method. | Predose (0 hour) up to 192 hours postdose |
| Maximum Measured Plasma Concentration (Cmax) of Total Mo | Predose (0 hour) up to 192 hours postdose | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | Day 1 through 14 days following final dose (up to Day 43) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Lincoln | Nebraska | 68502 | United States |
Participants were randomized to one of 6 treatment sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1: ABC | 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. |
| 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 | Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo) | AUC0-t was calculated by the linear trapezoidal method. | 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. | Posted | Mean | Standard Deviation | hours*ng/mL | Predose (0 hour) up to 192 hours postdose |
|
Day 1 through 14 days following final dose (up to Day 43)
All enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: ALXN1840 (Fasted) | ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid oedema | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals Inc. | Alexion Pharmaceuticals Inc. | +1 855-752-2356 | clinicaltrials@alexion.com |
Not provided
| ID | Term |
|---|---|
| D020742 | rhoA GTP-Binding Protein |
| C020809 | tetrathiomolybdate |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D020741 | rho GTP-Binding Proteins |
| D020559 | Monomeric GTP-Binding Proteins |
| D019204 | GTP-Binding Proteins |
| D020558 | GTP Phosphohydrolases |
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This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study.
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|
| Sequence 4: BCA | Experimental | Participants received each treatment on 1 occasion: Period 1 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing. |
|
| Sequence 5: CAB | Experimental | Participants received each treatment on 1 occasion: Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing. |
|
| Sequence 6: CBA | Experimental | Participants received each treatment on 1 occasion: Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing. |
|
|
| Omeprazole | Drug | Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1. |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | 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.
| OG002 | Treatment C: Omeprazole + ALXN1840 (Fed) | 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. |
|
|
|
| Primary | Maximum Measured Plasma Concentration (Cmax) of Total Mo | 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. | Posted | Mean | Standard Deviation | ng/mL | Predose (0 hour) up to 192 hours postdose |
|
|
|
|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | All enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 through 14 days following final dose (up to Day 43) |
|
|
|
| 0 |
| 18 |
| 6 |
| 18 |
| EG001 | Treatment B: Omeprazole + ALXN1840 (Fasted) | 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. | 0 | 18 | 5 | 18 |
| EG002 | Treatment C: Omeprazole + ALXN1840 (Fed) | 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. | 0 | 18 | 6 | 18 |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Superficial injury of eye | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
Not provided
| D017766 | Acid Anhydride Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Geometric Mean Ratio (%) |
| 95.94 |
| 2-Sided |
| 90 |
| 84.54 |
| 108.88 |
| Other |