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Bioavailability Study of 2 Oral Formulations of ALXN1840

Sponsor
Alexion Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04610580
Collaborator
(none)
48
Enrollment
1
Location
6
Arms
2.8
Actual Duration (Months)
17.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This is a 2-period, 2-sequence, crossover study with a parallel group extension.This is a 2-period, 2-sequence, crossover study with a parallel group extension.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jan 31, 2021
Actual Primary Completion Date :
Mar 24, 2021
Actual Study Completion Date :
Apr 26, 2021

Arms and Interventions

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:
  • Tiomolibdate choline
  • Tiomolibdic acid

    		•
    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:
  • Tiomolibdate choline
  • Tiomolibdic acid

    		•
    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:
  • Tiomolibdate choline
  • Tiomolibdic acid

    		•
    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:
  • Tiomolibdate choline
  • Tiomolibdic acid

    		•
    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:
  • Tiomolibdate choline
  • Tiomolibdic acid

    		•
    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:
  • Tiomolibdate choline
  • Tiomolibdic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Relative Bioavailability Of ALXN1840 Test And Reference Formulations As Assessed By Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo) and Plasma Ultrafiltrate (PUF) Mo [Period 1: up to 336 hours postdose and Period 2: up to 336 hours postdose]

    2. Relative Bioavailability Of ALXN1840 Test And Reference Formulations As Assessed By Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) For Plasma Total Mo and PUF Mo [Period 1: up to 336 hours postdose and Period 2: up to 336 hours postdose]

    3. Relative Bioavailability Of ALXN1840 Test And Reference Formulations As Assessed By Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo and PUF Mo [Period 1: up to 336 hours postdose and Period 2: up to 336 hours postdose]

    Secondary Outcome Measures

    1. Extension Period: Dose-proportionality Between 4 Ascending Doses Of ALXN1840 As Assessed by Dose-normalized Cmax For Plasma Total Mo and PUF Mo [up to 336 hours postdose]

    2. Extension Period: Dose-proportionality Between 4 Ascending Doses Of ALXN1840 As Assessed by Dose-normalized AUCt For Plasma Total Mo and PUF Mo [up to 336 hours postdose]

    3. Extension Period: Dose-proportionality Between 4 Ascending Doses Of ALXN1840 As Assessed by Dose-normalized AUCinf For Plasma Total Mo and PUF Mo [up to 336 hours postdose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nucleus Network Pty Ltd. Melbourne Victoria Australia 3004

    Sponsors and Collaborators

    • Alexion Pharmaceuticals

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alexion Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04610580
    Other Study ID Numbers:
    • ALXN1840-HV-109
    First Posted:
    Oct 30, 2020
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Alexion Pharmaceuticals
    Bioavailability
    Healthy
    Additional relevant MeSH terms:
    Choline

    Study Results

    No Results Posted as of Apr 1, 2022