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Completed

NCT Number: NCT04952545

Study of ALXN2050 in Healthy Adult Participants of Japanese Descent

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALXN2050

Drug

Oral tablet.

Other names: ACH-0145228 (formerly)

Placebo

Drug

Oral tablet.

Primary outcomes

  1. Number Of Participants With Treatment-emergent Adverse Events

    Time frame: Day 1 (after first dose) through follow-up (7 +/- 2 days after final dose)

    see Time Frame - defined

  2. Area Under The Concentration-time Curve From Time Zero To Infinity (AUCinf) For Single-dose ALXN2050

    Time frame: Up to 72 hours postdose

    see Time Frame - defined

  3. Maximum Plasma Concentration (Cmax) For Single-dose ALXN2050

    Time frame: Up to 72 hours postdose

    see Time Frame - defined

  4. Time To Maximum Plasma Concentration (Tmax) For Single-dose ALXN2050

    Time frame: Up to 72 hours postdose

    see Time Frame - defined

  5. Area Under The Concentration-time Curve From Time Zero To The 12-hour Time Point (AUC0-12) For Multiple-dose ALXN2050

    Time frame: Up to 72 hours postdose

    see Time Frame - defined

  6. Cmax For Multiple-dose ALXN2050

    Time frame: Up to 72 hours postdose

    see Time Frame - defined

  7. Tmax For Multiple-dose ALXN2050

    Time frame: Up to 72 hours postdose

    see Time Frame - defined

Secondary outcomes

  1. Alternative Pathway Activity As Measured By Wieslab Assay

    Time frame: Up to 72 hours postdose

    see Time Frame - defined

  2. Complement Factor B Fraction b Levels

    Time frame: Up to 72 hours postdose

    see Time Frame - defined

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2021
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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