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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT05641311
• Date of registration: 29/11/2022
• Prospective Registration: No
• Primary sponsor: Alexion Pharmaceuticals, Inc.
• Public title: Pharmacokinetic Study of Oral ALXN1840 in Japanese and Non-Japanese Adult Healthy Participants
• Scientific 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
• Date of first enrolment: February 20, 2019
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT05641311
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Wilson Disease

Intervention(s)

Drug: ALXN1840

Primary Outcome(s)

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]

Secondary ID(s)

2018-004483-57

C18055

WTX101-HV-106

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/11/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT05641311