Study of ALXN2050 in Healthy Adult Participants of Japanese Descent

Healthy Clinical Trial

Official title:

A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALXN2050 in Healthy Participants of Japanese Descent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04952545
• Other study ID #: ALXN2050-HV-113
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2021
• Est. completion date: September 7, 2021

Study information

• Verified date: December 2022
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1 bridging study being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALXN2050 after both single- and multiple-dosing in healthy participants of Japanese descent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 7, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.

• Participants must be of Japanese descent defined as:

• First generation (born to 2 Japanese parents and 4 Japanese grandparents);

• Born in Japan, and not have lived outside Japan for greater than 5 years;

• Lifestyle, including diet, must not have significantly changed since leaving Japan.

• Participants must be able to speak, read, and understand the Japanese and English languages.

• Body mass index within the range 18.5 to 30.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.

Key Exclusion Criteria:

• History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.

• History of significant multiple and/or severe allergies.

• Any previous procedure that could alter absorption or excretion of orally administered drugs.

• Participation in another investigational drug or investigational device study within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.

• Body temperature = 38.0°Celcius, at Screening or prior to the first dose of study intervention.

• History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco/nicotine users or smokers or a positive cotinine test at Screening.

• Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN2050
Oral tablet.
• Placebo
Oral tablet.

Locations

Country	Name	City	State
United States	Clinical Trial Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Of Participants With Treatment-emergent Adverse Events	see Time Frame - defined	Day 1 (after first dose) through follow-up (7 +/- 2 days after final dose)
Primary	Area Under The Concentration-time Curve From Time Zero To Infinity (AUCinf) For Single-dose ALXN2050	see Time Frame - defined	Up to 72 hours postdose
Primary	Maximum Plasma Concentration (Cmax) For Single-dose ALXN2050	see Time Frame - defined	Up to 72 hours postdose
Primary	Time To Maximum Plasma Concentration (Tmax) For Single-dose ALXN2050	see Time Frame - defined	Up to 72 hours postdose
Primary	Area Under The Concentration-time Curve From Time Zero To The 12-hour Time Point (AUC0-12) For Multiple-dose ALXN2050	see Time Frame - defined	Up to 72 hours postdose
Primary	Cmax For Multiple-dose ALXN2050	see Time Frame - defined	Up to 72 hours postdose
Primary	Tmax For Multiple-dose ALXN2050	see Time Frame - defined	Up to 72 hours postdose
Secondary	Alternative Pathway Activity As Measured By Wieslab Assay	see Time Frame - defined	Up to 72 hours postdose
Secondary	Complement Factor B Fraction b Levels	see Time Frame - defined	Up to 72 hours postdose