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

NCT ID: NCT05319899

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-20
• Study Completion Date: 2014-03-24

Brief Summary

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 Molybdenum.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sequence 1: ABC

Participants received each treatment on 1 occasion:

Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment B): 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 at Hour 0 on Day 1, 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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.

There was a washout period of at least 14 days between each ALXN1840 dosing.

Group Type: EXPERIMENTAL

ALXN1840

Intervention Type: DRUG

ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.

Omeprazole

Intervention Type: 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.

Sequence 2: ACB

Participants received each treatment on 1 occasion:

Period 1 (Treatment A): ALXN1840 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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): 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 at Hour 0 on Day 1, following an overnight fast.

There was a washout period of at least 14 days between each ALXN1840 dosing.

Group Type: EXPERIMENTAL

ALXN1840

Intervention Type: DRUG

ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.

Omeprazole

Intervention Type: 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.

Sequence 3: BAC

Participants received each treatment on 1 occasion:

Period 1 (Treatment B): 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 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.

There was a washout period of at least 14 days between each ALXN1840 dosing.

Group Type: EXPERIMENTAL

ALXN1840

Intervention Type: DRUG

ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.

Omeprazole

Intervention Type: 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.

Sequence 4: BCA

Participants received each treatment on 1 occasion:

Period 1 (Treatment B): 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 at Hour 0 on Day 1, 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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 following an overnight fast.

There was a washout period of at least 14 days between each ALXN1840 dosing.

Group Type: EXPERIMENTAL

ALXN1840

Intervention Type: DRUG

ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.

Omeprazole

Intervention Type: 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.

Sequence 5: CAB

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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment B): 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 at Hour 0 on Day 1, following an overnight fast.

There was a washout period of at least 14 days between each ALXN1840 dosing.

Group Type: EXPERIMENTAL

ALXN1840

Intervention Type: DRUG

ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.

Omeprazole

Intervention Type: 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.

Sequence 6: CBA

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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): 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 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 following an overnight fast.

There was a washout period of at least 14 days between each ALXN1840 dosing.

Group Type: EXPERIMENTAL

ALXN1840

Intervention Type: DRUG

ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.

Omeprazole

Intervention Type: 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.

Interventions

ALXN1840

ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.

Intervention Type: DRUG

Omeprazole

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.

Intervention Type: DRUG

Other Intervention Names

WTX101 (formerly); Bis-choline tetrathiomolybdate; Tiomolibdate choline; Prilosec

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

CA12887

Identifier Type: OTHER

Identifier Source: secondary_id

WTX101-101

Identifier Type: -

Identifier Source: org_study_id