A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ALXN1840 Non-coated Capsule; Drug: ALXN1840 Enteric-coated Tablet; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT05319912

CA13895 (Other Identifier)

WTX101-102

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 mentally or legally incapacitated
• History or presence of clinically significant medical or psychiatric condition or disease.
• History of any illness that might have interfered with drug absorption.
• History or presence of hypersensitivity or idiosyncratic reaction to the study medications, study medication excipients.
• History or presence of alcoholism or drug abuse.
• Female participants who were pregnant or lactating.
• Positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.
• Serum ceruloplasmin and copper values outside of the normal range at screening.
• On a diet incompatible with the on-study diet within the 28 days prior to the first ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat breakfast.
• Participation in a previous clinical trial with ALXN1840.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

Sequence 1: ABC

Experimental group

Description:

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.

Treatment:

Drug: Omeprazole

Drug: ALXN1840 Enteric-coated Tablet

Drug: ALXN1840 Non-coated Capsule

Sequence 2: ACB

Experimental group

Description:

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.

Treatment:

Drug: Omeprazole

Drug: ALXN1840 Enteric-coated Tablet

Drug: ALXN1840 Non-coated Capsule

Sequence 3: BAC

Experimental group

Description:

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.

Treatment:

Drug: Omeprazole

Drug: ALXN1840 Enteric-coated Tablet

Drug: ALXN1840 Non-coated Capsule

Sequence 4: BCA

Experimental group

Description:

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.

Treatment:

Drug: Omeprazole

Drug: ALXN1840 Enteric-coated Tablet

Drug: ALXN1840 Non-coated Capsule

Sequence 5: CAB

Experimental group

Description:

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.

Treatment:

Drug: Omeprazole

Drug: ALXN1840 Enteric-coated Tablet

Drug: ALXN1840 Non-coated Capsule

Sequence 6: CBA

Experimental group

Description:

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.

Treatment:

Drug: Omeprazole

Drug: ALXN1840 Enteric-coated Tablet

Drug: ALXN1840 Non-coated Capsule