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

September 15, 2022 updated by: Alexion

A Phase 1, Single-Center, Randomized, 3-Period Crossover Study in Healthy Volunteers to Evaluate the Absorption of WTX101 After Single Dose Administration of an Enteric Coated Formulation With and Without Food and a Non-Coated Formulation Coadministered With a Proton Pump Inhibitor Without Food

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1: ABC

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.
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.
Other Names:
  • Prilosec
Drug: ALXN1840 Enteric-coated Tablet
ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Drug: ALXN1840 Non-coated Capsule
ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Experimental: Sequence 2: ACB

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.
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.
Other Names:
  • Prilosec
Drug: ALXN1840 Enteric-coated Tablet
ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Drug: ALXN1840 Non-coated Capsule
ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Experimental: Sequence 3: BAC

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.
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.
Other Names:
  • Prilosec
Drug: ALXN1840 Enteric-coated Tablet
ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Drug: ALXN1840 Non-coated Capsule
ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Experimental: Sequence 4: BCA

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.
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.
Other Names:
  • Prilosec
Drug: ALXN1840 Enteric-coated Tablet
ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Drug: ALXN1840 Non-coated Capsule
ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Experimental: 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 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.
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.
Other Names:
  • Prilosec
Drug: ALXN1840 Enteric-coated Tablet
ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Drug: ALXN1840 Non-coated Capsule
ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Experimental: 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 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.
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.
Other Names:
  • Prilosec
Drug: ALXN1840 Enteric-coated Tablet
ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)
Drug: ALXN1840 Non-coated Capsule
ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.
Other Names:
  • Tiomolibdate choline
  • Bis-choline tetrathiomolybdate
  • WTX101 (formerly)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)
Time Frame: Predose (0 hour) up to 192 hours postdose
AUC0-t was calculated by the linear trapezoidal method.
Predose (0 hour) up to 192 hours postdose
Maximum Measured Plasma Concentration (Cmax) of Total Mo
Time Frame: Predose (0 hour) up to 192 hours postdose
Predose (0 hour) up to 192 hours postdose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Day 1 through 14 days following final dose (up to Day 43)
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.
Day 1 through 14 days following final dose (up to Day 43)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2014

Primary Completion (Actual)

May 29, 2014

Study Completion (Actual)

May 29, 2014

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WTX101-102
  • CA13895 (Other Identifier: Celerion)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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