Bioavailability Study of 2 Oral Formulations of ALXN1840

A Phase 1, Randomized, 2-period, 2-sequence, Crossover With Parallel-group Extension, Open-label Study to Compare the Relative Bioavailability of 2 Oral Formulations of ALXN1840 in Healthy Adult Participants

The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ALXN1840

Detailed Description

This is a two-way crossover study consisting of 2 dosing periods assessing a test and reference formulation of ALXN1840. A dose-proportionality parallel group design extension period will be conducted following completion of the two-way crossover period of the study and will assess 5 different ascending doses of ALXN1840. There will be at least a 14-day washout following doses between Periods 1 and 2 and also at least a 14-day washout following the dose in Period 2 and the following dose in the Dose-Proportionality Extension Period.

Safety will be assessed throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network Pty Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• No clinically significant history or presence of electrocardiogram findings
• Body weight ≥50 to ≤100 kilograms (kg) and body mass index 18 to <32 kg/meter squared for all participants
• Willing and able to follow protocol-specified contraception requirements

Exclusion Criteria:

• History or presence of clinical and/or laboratory disorders
• Abnormal blood pressure, defined as supine blood pressure ≤90/60 millimeters of mercury (mmHg) or >140/90 mmHg
• Lymphoma, leukemia, or any malignancy within the past 5 years
• Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > upper limit of normal
• Serum copper or serum ceruloplasmin below lower limit of normal
• Hemoglobin <130 grams (g)/liter (L) for males and hemoglobin <115 g/L for females
• Significant allergies
• Smoker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crossover ALXN1840 Sequence 1; Participants will first receive a single dose of ALXN1840 test formulation on Day 1 of Period 1. After a washout period of 14 days, they will then receive a single dose of ALXN1840 reference formulation on Day 1 of Period 2.	Drug: ALXN1840; ALXN1840 will be administered orally.; Other Names: Tiomolibdic acid; Tiomolibdate choline
Experimental: Crossover ALXN1840 Sequence 2; Participants will first receive a single dose of ALXN1840 reference formulation on Day 1 of Period 1. After a washout period of 14 days, they will then receive a single dose of ALXN1840 test formulation on Day 1 of Period 2.	Drug: ALXN1840; ALXN1840 will be administered orally.; Other Names: Tiomolibdic acid; Tiomolibdate choline
Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 1; Participants will receive a single dose of ALXN1840.	Drug: ALXN1840; ALXN1840 will be administered orally.; Other Names: Tiomolibdic acid; Tiomolibdate choline
Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 2; Participants will receive a single dose of ALXN1840.	Drug: ALXN1840; ALXN1840 will be administered orally.; Other Names: Tiomolibdic acid; Tiomolibdate choline
Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 3; Participants will receive a single dose of ALXN1840.	Drug: ALXN1840; ALXN1840 will be administered orally.; Other Names: Tiomolibdic acid; Tiomolibdate choline
Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 4; Participants will receive a single dose of ALXN1840.	Drug: ALXN1840; ALXN1840 will be administered orally.; Other Names: Tiomolibdic acid; Tiomolibdate choline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via inductively coupled plasma-mass spectroscopy (ICP-MS).	predose (0.5 hour) and up to 336 hours postdose
Two-way Crossover Period: Cmax for PUF Mo	Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) For Plasma Total Mo	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Two-way Crossover Period: AUCt for Plasma PUF Mo	Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-Proportionality Extension Period: Cmax For Plasma Total Mo	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo	Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: AUCt For Plasma Total Mo	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo	Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals, Inc.
• Investigators: Study Director: Eugene S. Swenson, MD, PhD, Alexion Pharmaceuticals, Inc.; Study Chair: Masood Sadaat, MD, MSc, Alexion Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2021
• Primary Completion (Actual): March 24, 2021
• Study Completion (Actual): April 26, 2021

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Healthy; Bioavailability
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: ALXN1840-HV-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes