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OpenTrials
Completed

NCT Number: NCT05303324

Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults

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).

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

London, SE11YR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

ALXN1840

Drug

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

Other names: Bis-choline Tetrathiomolybdate, Tiomolibdic Acid, WTX101 (formerly)

Primary outcomes

  1. Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum

    Time frame: Up to 240 hours postdose

    The pharmacokinetic (PK) data of plasma total molybdenum were analyzed in the scope of this study as a surrogate measure for ALXN1840. Whole blood samples were collected for the measurement of plasma concentrations of total molybdenum via inductively coupled plasma-mass spectroscopy (ICP-MS).

  2. Area Under The Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt) of Total Molybdenum

    Time frame: Up to 240 hours postdose

    The PK data of plasma total molybdenum were analyzed in the scope of this study as a surrogate measure for ALXN1840. Whole blood samples were collected for the measurement of plasma concentrations of total molybdenum via ICP-MS.

Secondary outcomes

  1. Number of Participants With a Treatment-Emergent Adverse Event (TEAEs)

    Time frame: Baseline up to Day 43

    An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was an AE that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose. A related TEAE was defined as having a reasonable possibility the study intervention caused the AE as assessed by the investigator. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (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, Randomized, Open-Label, 2-Way Crossover Study to Assess the Single-Dose Pharmacokinetics of ALXN1840 Enteric-Coated Tablets at 2 Dose Strengths in Healthy Adult Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 31, 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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