Study of ALXN2050 in Healthy Adult Participants of Japanese Descent

Sponsor

Alexion Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04952545

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ALXN2050 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 9, 2021

Actual Primary Completion Date :

Sep 7, 2021

Actual Study Completion Date :

Sep 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: ALXN2050 (Dose 1) Participants will receive ALXN2050 (Dose 1) as follows under fasting conditions: 120-milligrams (mg) single dose, 3-day washout, then 120-mg twice daily (BID) dosing.	Drug: ALXN2050 Oral tablet. Other Names: ACH-0145228 (formerly)
Experimental: Cohort 1: Placebo (Dose 1) Participants will receive placebo (Dose 1) as follows under fasting conditions: 120-mg placebo single dose, 3-day washout, then 120-mg placebo BID dosing.	Drug: Placebo Oral tablet.
Experimental: Cohort 2: ALXN2050 (Dose 2) Participants will receive ALXN2050 (Dose 2) as follows under fasting conditions: 180-mg single dose, 3-day washout, then 180-mg BID dosing.	Drug: ALXN2050 Oral tablet. Other Names: ACH-0145228 (formerly)
Experimental: Cohort 2: Placebo (Dose 2) Participants will receive placebo (Dose 2) as follows under fasting conditions: 180-mg placebo single dose, 3-day washout, then 180-mg placebo BID dosing.	Drug: Placebo Oral tablet.

Outcome Measures

Primary Outcome Measures

Number Of Participants With Treatment-emergent Adverse Events [Day 1 (after first dose) through follow-up (7 +/- 2 days after final dose)]
Area Under The Concentration-time Curve From Time Zero To Infinity (AUCinf) For Single-dose ALXN2050 [Up to 72 hours postdose]
Maximum Plasma Concentration (Cmax) For Single-dose ALXN2050 [Up to 72 hours postdose]
Time To Maximum Plasma Concentration (Tmax) For Single-dose ALXN2050 [Up to 72 hours postdose]
Area Under The Concentration-time Curve From Time Zero To The 12-hour Time Point (AUC0-12) For Multiple-dose ALXN2050 [Up to 72 hours postdose]
Cmax For Multiple-dose ALXN2050 [Up to 72 hours postdose]
Tmax For Multiple-dose ALXN2050 [Up to 72 hours postdose]

Secondary Outcome Measures

Alternative Pathway Activity As Measured By Wieslab Assay [Up to 72 hours postdose]
Complement Factor B Fraction b Levels [Up to 72 hours postdose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trial Site	Tempe	Arizona	United States	85283

Sponsors and Collaborators

Alexion Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexion Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04952545

Other Study ID Numbers:

ALXN2050-HV-113

First Posted:

Jul 7, 2021

Last Update Posted:

Dec 10, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alexion Pharmaceuticals

Study Results

No Results Posted as of Dec 10, 2021