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Pharmacokinetic Study of Oral ALXN1840 in Japanese and Non-Japanese Adult Healthy Participants

Primary Purpose

Wilson Disease

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ALXN1840
Sponsored by
Alexion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Wilson Disease

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria: - Body weight ≤80 kilograms (kg) and body mass index (BMI) within the range 18-25 kg/m^2, inclusive, at screening. - Negative serum pregnancy test. - Female participants of childbearing potential and male participants with a female spouse or partner of childbearing potential must be willing to follow protocol-specified contraception guidance starting at least one menstrual cycle before first study drug administration and continuing for up to 3 months after the end of systemic exposure of the study drug (that is, 3 months after end of study visit). Key Exclusion Criteria: - Current or recurrent/chronic disease (for example, cardiovascular, hematological, neurological, endocrine, immunological, rheumatological, renal, hepatic, or gastrointestinal (GI) or other conditions) that or could affect clinical assessments or clinical laboratory evaluations. - Current or relevant history of physical or psychiatric illness that are not stable or may require a change in treatment, use of prohibited therapies during the study or make the participant unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the study drug or study procedures. - Any other significant disease or disorder which, in the opinion of the Investigator, may put the participant at risk. - History of significant allergic reaction (for example, anaphylaxis or angioedema) to any product (for example, food, pharmaceutical). - Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of Alexion. - Use of non-prescription/ over-the-counter medications including vitamins and dietary or herbal supplements, within 7 days prior to dosing on Day 1. - Donated or lost 400 milliliters (mL) blood or more within the last 16 weeks preceding the first day of dosing.

Sites / Locations

  • Richmond Pharmacology Ltd., St George's University of London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1: Japanese Participants

Cohort 2: Non-Japanese Participants

Arm Description

All Japanese participants will receive a single dose of ALXN1840 15 milligrams (mg) in Dosing Period 1 and will receive a single dose of ALXN1840 60 mg in Dosing Period 2.

All non-Japanese participants will receive a single dose of ALXN1840 15 mg in Dosing Period 1 and will receive a single dose of ALXN1840 60 mg in Dosing Period 2.

Outcomes

Primary Outcome Measures

Area Under The Plasma Concentration Versus Time Curve From Time 0 (Dosing) To The Last Quantifiable Concentration (AUCt) Of Plasma Total Molybdenum After Each Dose

Secondary Outcome Measures

Full Information

First Posted
November 29, 2022
Last Updated
November 29, 2022
Sponsor
Alexion
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1. Study Identification

Unique Protocol Identification Number
NCT05641311
Brief Title
Pharmacokinetic Study of Oral ALXN1840 in Japanese and Non-Japanese Adult Healthy Participants
Official Title
An Open-Label, Two-Single Dose, Two-Period, Parallel Group Study to Assess the Pharmacokinetics and Safety of ALXN1840 in Healthy Adult Japanese and Non-Japanese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
May 2, 2019 (Actual)
Study Completion Date
May 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of the study is to confirm how long ALXN1840 stays in the body of Japanese and non-Japanese healthy participants (that is, pharmacokinetic [PK] profile).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wilson Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Japanese Participants
Arm Type
Experimental
Arm Description
All Japanese participants will receive a single dose of ALXN1840 15 milligrams (mg) in Dosing Period 1 and will receive a single dose of ALXN1840 60 mg in Dosing Period 2.
Arm Title
Cohort 2: Non-Japanese Participants
Arm Type
Experimental
Arm Description
All non-Japanese participants will receive a single dose of ALXN1840 15 mg in Dosing Period 1 and will receive a single dose of ALXN1840 60 mg in Dosing Period 2.
Intervention Type
Drug
Intervention Name(s)
ALXN1840
Intervention Description
Tablet for oral use.
Primary Outcome Measure Information:
Title
Area Under The Plasma Concentration Versus Time Curve From Time 0 (Dosing) To The Last Quantifiable Concentration (AUCt) Of Plasma Total Molybdenum After Each Dose
Time Frame
Day 1 through Day 11 of Dosing Periods 1 and 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: - Body weight ≤80 kilograms (kg) and body mass index (BMI) within the range 18-25 kg/m^2, inclusive, at screening. - Negative serum pregnancy test. - Female participants of childbearing potential and male participants with a female spouse or partner of childbearing potential must be willing to follow protocol-specified contraception guidance starting at least one menstrual cycle before first study drug administration and continuing for up to 3 months after the end of systemic exposure of the study drug (that is, 3 months after end of study visit). Key Exclusion Criteria: - Current or recurrent/chronic disease (for example, cardiovascular, hematological, neurological, endocrine, immunological, rheumatological, renal, hepatic, or gastrointestinal (GI) or other conditions) that or could affect clinical assessments or clinical laboratory evaluations. - Current or relevant history of physical or psychiatric illness that are not stable or may require a change in treatment, use of prohibited therapies during the study or make the participant unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the study drug or study procedures. - Any other significant disease or disorder which, in the opinion of the Investigator, may put the participant at risk. - History of significant allergic reaction (for example, anaphylaxis or angioedema) to any product (for example, food, pharmaceutical). - Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of Alexion. - Use of non-prescription/ over-the-counter medications including vitamins and dietary or herbal supplements, within 7 days prior to dosing on Day 1. - Donated or lost 400 milliliters (mL) blood or more within the last 16 weeks preceding the first day of dosing.
Facility Information:
Facility Name
Richmond Pharmacology Ltd., St George's University of London
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetic Study of Oral ALXN1840 in Japanese and Non-Japanese Adult Healthy Participants

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