Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults

NCT ID: NCT05303324

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2019-10-09

Brief Summary

To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).

Conditions

Healthy

Study Design

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

Study Groups

Sequence 1 (AB)

Participants received ALXN1840 once in each Period as a single oral dose under fasted conditions as follows:

Period 1: ALXN1840 as a single EC tablet (Treatment A, reference). Period 2: ALXN1840 as three EC tablets (Treatment B, test).

Participants were discharged following the 240-hour post-dose procedures (approximately 10 days after dosing in each period) unless it was medically necessary to extend the confinement.

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

Group Type: EXPERIMENTAL

ALXN1840

Intervention Type: DRUG

Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period.

Sequence 2 (BA)

Participants received ALXN1840 once in each Period as a single oral dose under fasted conditions as follows:

Period 1: ALXN1840 as three EC tablets (Treatment B, test). Period 2: ALXN1840 as a single EC tablet (Treatment A, reference).

Participants were discharged following the 240-hour post-dose procedures (approximately 10 days after dosing in each period) unless it was medically necessary to extend the confinement.

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

Group Type: EXPERIMENTAL

ALXN1840

Intervention Type: DRUG

Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period.

Interventions

ALXN1840

Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period.

Intervention Type: DRUG

Other Intervention Names

Bis-choline Tetrathiomolybdate; Tiomolibdic Acid; WTX101 (formerly)

Eligibility Criteria

Inclusion Criteria

• Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
• Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
• Willing to adhere to contraception requirements.
• Satisfactory medical assessment with no clinically significant or relevant abnormalities.

Exclusion Criteria

• Current or recurrent/chronic disease
• Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
• Acute or chronic hepatitis C virus infection.
• History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
• Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
• Participation (that is, last protocol-required study visit) in a clinical study within 90 days before initiation of dosing on Day 1.
• Serum ceruloplasmin value outside of the normal range at Screening
• Female participants who were breastfeeding.
• Prior exposure to ALXN1840.
• Major surgery or hospitalization within 90 days prior to dosing on Day 1.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 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

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-000516-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALXN1840-HV-104

Identifier Type: -

Identifier Source: org_study_id