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

Phase 1CompletedNCT05319912

Alexion Pharmaceuticals, Inc.18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

ALXN1840 Enteric-coated TabletDRUG

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

ALXN1840 Non-coated CapsuleDRUG

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

OmeprazoleDRUG

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Trial Site

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)

AUC0-t was calculated by the linear trapezoidal method.

Time frame: 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

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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.

Time frame: Day 1 through 14 days following final dose (up to Day 43)

Data from ClinicalTrials.gov

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