Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CA13895 | Other Identifier | Celerion |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Mo concentration.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: ABC | Experimental | Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 tablets following an overnight fast. Period 2 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by 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 non-coated capsules at Hour 0 on Day 1. 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 tablets 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 non-coated capsules at Hour 0 on Day 1. Period 3 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by 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): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment A): ALXN1840 tablets 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 non-coated capsules at Hour 0 on Day 1. There was a washout period of at least 14 days between each ALXN1840 dosing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1840 Enteric-coated Tablet | Drug | ALXN1840 (60 milligrams) was administered orally as EC tablets 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Lincoln | Nebraska | 68502 | United States |
Participants were randomized to one of 6 treatment sequences.
Not provided
Not provided
| 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 enteric-coated [EC] tablets) at Hour 0 on Day 1 following an overnight fast. Period 2 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment C): 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. 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 EC tablets) 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 3 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by 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): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. 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): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast. Period 3 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 2 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 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 EC tablets) at Hour 0 on Day 1 following an overnight fast. Period 2 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. 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 enrolled participants who completed 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 EC tablets) at Hour 0 on Day 1 following an overnight fast. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals Inc. | Alexion Pharmaceuticals Inc. | +1 855-752-2356 | clinicaltrials@alexion.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 24, 2014 | Sep 15, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2014 | Sep 15, 2022 | SAP_001.pdf |
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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sequence 4: BCA | Experimental | Participants received each treatment on 1 occasion: Period 1 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by 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 non-coated capsules at Hour 0 on Day 1. Period 3 (Treatment A): ALXN1840 tablets 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 non-coated capsules at Hour 0 on Day 1. Period 2 (Treatment A): ALXN1840 tablets following an overnight fast. Period 3 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by 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 non-coated capsules at Hour 0 on Day 1. Period 2 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment A): ALXN1840 tablets following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing. |
|
|
| ALXN1840 Non-coated Capsule | Drug | ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1. |
|
|
| 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 EC tablets) 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 3 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by 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): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. 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): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast. Period 3 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 2 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 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 |
|
| OG002 | Treatment C: 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. |
|
|
|
| Primary | Maximum Measured Plasma Concentration (Cmax) of Total Mo | PK analysis population included all enrolled participants who completed 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 |
| 4 |
| 18 |
| EG001 | Treatment B: ALXN1840 (Fed) | ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. | 0 | 18 | 2 | 18 |
| EG002 | Treatment C: 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 delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. | 0 | 18 | 6 | 18 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | 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 (%) |
| 40.49 |
| 2-Sided |
| 90 |
| 31.12 |
| 52.68 |
| Other |