NCT05641311

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2019

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 29, 2022

Results QC Date

December 15, 2022

Last Update Submit

November 2, 2023

Conditions

Wilson Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1 through Day 11 of Dosing Periods 1 and 2

Study Arms (2)

Cohort 1: Japanese Participants

EXPERIMENTAL

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.

Drug: ALXN1840

Cohort 2: Non-Japanese Participants

EXPERIMENTAL

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.

Drug: ALXN1840

Interventions

ALXN1840DRUG

Tablet for oral use.

Cohort 1: Japanese ParticipantsCohort 2: Non-Japanese Participants

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, United Kingdom

Location

MeSH Terms

Conditions

Hepatolenticular Degeneration

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsMetal Metabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

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
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 7, 2022

Study Start

February 20, 2019

Primary Completion

May 2, 2019

Study Completion

May 2, 2019

Last Updated

November 7, 2023

Results First Posted

November 7, 2023

Record last verified: 2023-11

Locations

GB(1)