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Completed

NCT Number: NCT04610580

Bioavailability Study of 2 Oral Formulations of ALXN1840

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Pty Ltd.

Melbourne, Victoria, 3004, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

ALXN1840

Drug

ALXN1840 will be administered orally.

Other names: Tiomolibdate choline, Tiomolibdic acid

Primary outcomes

  1. Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)

    Time frame: predose (0.5 hour) and up to 336 hours postdose

    Whole blood samples were collected for the measurement of plasma concentrations of total Mo via inductively coupled plasma-mass spectroscopy (ICP-MS).

  2. Two-way Crossover Period: Cmax for PUF Mo

    Time frame: predose (0.5 hour) and up to 336 hours postdose

    Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.

  3. 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

    Time frame: predose (0.5 hour) and up to 336 hours postdose

    Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.

  4. Two-way Crossover Period: AUCt for Plasma PUF Mo

    Time frame: predose (0.5 hour) and up to 336 hours postdose

    Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.

  5. Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo

    Time frame: predose (0.5 hour) and up to 336 hours postdose

    Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.

Secondary outcomes

  1. Dose-Proportionality Extension Period: Cmax For Plasma Total Mo

    Time frame: predose (0.5 hour) and up to 336 hours postdose

    Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.

  2. Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo

    Time frame: predose (0.5 hour) and up to 336 hours postdose

    Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.

  3. Dose-Proportionality Extension Period: AUCt For Plasma Total Mo

    Time frame: predose (0.5 hour) and up to 336 hours postdose

    Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.

  4. Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo

    Time frame: predose (0.5 hour) and up to 336 hours postdose

    Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.

  5. Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo

    Time frame: predose (0.5 hour) and up to 336 hours postdose

    Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2020
Registry last updated
Jan 16, 2024

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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