Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied in healthy adults. It is currently in Phase 1 clinical development, with a completed trial evaluating its administration with and without omeprazole. The drug is not approved for any indication and remains under investigation.
ALXN1840 Enteric-coated is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this investigational small molecule in healthy volunteers as part of early-stage development.
ALXN1840 Enteric-coated is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing early-stage clinical testing.
ALXN1840 Enteric-coated has one completed clinical trial, NCT05319912, titled "A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults." This Phase 1 study enrolled 18 participants in the United States and evaluated the drug's effects in healthy volunteers.
ALXN1840 Enteric-coated is a coated formulation of ALXN1840. The clinical trial NCT05319912 specifically studied both coated and non-coated versions of ALXN1840, administered with and without omeprazole, to compare their effects in healthy adults.