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Completed

NCT Number: NCT05319912

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

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.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALXN1840 Enteric-coated Tablet

Drug

ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.

Other names: WTX101 (formerly), Bis-choline tetrathiomolybdate, Tiomolibdate choline

ALXN1840 Non-coated Capsule

Drug

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

Other names: WTX101 (formerly), Bis-choline tetrathiomolybdate, Tiomolibdate choline

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.

Other names: Prilosec

Primary outcomes

  1. 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.

  2. Maximum Measured Plasma Concentration (Cmax) of Total Mo

    Time frame: Predose (0 hour) up to 192 hours postdose

  3. 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.

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2022
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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