Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults

NCT05303324 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: ALXN1840-HV-1042019-000516-28
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

ALXN1840; Enteric-coated tablet; Pharmacokinetics; Pharmacodynamics; Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum

  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).

  Up to 240 hours postdose

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

  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.

  Up to 240 hours postdose

Secondary Outcomes (1)

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

  Baseline up to Day 43

Study Arms (2)

Sequence 1 (AB)

EXPERIMENTAL

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.

Drug: ALXN1840

Sequence 2 (BA)

EXPERIMENTAL

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.

Drug: ALXN1840

Interventions

ALXN1840 DRUG

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

Also known as: Bis-choline Tetrathiomolybdate, Tiomolibdic Acid, WTX101 (formerly)

Sequence 1 (AB); Sequence 2 (BA)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Trial Site

London, SE11YR, United Kingdom

Location

MeSH Terms

Interventions

tetrathiomolybdate; rhoA GTP-Binding Protein

Intervention Hierarchy (Ancestors)

rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Intracellular Signaling Peptides and Proteins

Results Point of Contact

• Title: Alexion Pharmaceuticals, Inc.
• Organization: Alexion Pharmaceuticals, Inc.

clinicaltrials@alexion.com

+1.855.752.2356

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: July 4, 2019
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: August 2, 2023
• Results First Posted: August 2, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)