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

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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)

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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