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Also known as ALXN1840 Enteric-coated Tablet
ALXN1840 Enteric-coated · 1 trial · 1 indication
AUC0-t was calculated by the linear trapezoidal method.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| ALXN1840 Enteric-coated Tablet | DRUG | ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1. |
| 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. |
Inclusion Criteria: * Non-smoker * Medically healthy with no clinically significant laboratory profiles, vital signs, or electrocardiograms. * Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared. * Willing and able to adhere to contraception requirements. Exclusion Criteria: * Participant was...
ALXN1840 Enteric-coated is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It is an enteric-coated tablet formulation studied in healthy adult volunteers. The clinical program to date consists of a single completed Phase 1 trial, and no therapeutic indication has been disclosed for this formulation.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of ALXN1840 Enteric-coated. The company sponsored the Phase 1 study of the coated and non-coated tablet formulations administered with and without omeprazole in healthy adults.
ALXN1840 Enteric-coated is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials of this formulation are currently listed.
ALXN1840 Enteric-coated has been studied in one completed Phase 1 trial, NCT05319912, titled A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults. The trial enrolled 18 healthy volunteers in the United States, used a controlled design, and included both male and female participants aged 19 years and older.
Yes. ALXN1840 Enteric-coated and ALXN1840 Enteric-coated Tablet refer to the same investigational AstraZeneca product. The enteric-coated tablet is the oral formulation studied in the completed Phase 1 trial NCT05319912, which evaluated the coated and non-coated forms with and without omeprazole in healthy adults.