Study of Radiolabeled ALXN2050 in Healthy Adult Males

January 23, 2023 updated by: Alexion Pharmaceuticals

A Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-ALXN2050 in Healthy Adult Male Subjects

This is an open-label study to assess the absorption, metabolism, excretion, and mass balance of a single oral dose of carbon-14 ([14C])-ALXN2050 in healthy adult males.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. No clinically significant medical history, physical or neurological examination findings, screening clinical laboratory profiles, or electrocardiogram findings.
  2. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
  3. Non-sterile participants must agree to abstinence or use a highly effective method of contraception.

Exclusion Criteria:

  1. History of any medical or psychiatric condition or disease that 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.
  2. History or presence of drug or alcohol abuse within previous 2 years, current user of tobacco/any nicotine-containing product, or positive drugs-of-abuse screen or alcohol screen at screening or Day -1 of Period 1.
  3. History or presence of seizures, head injury, or head trauma.
  4. History of procedures that could alter absorption or excretion of orally administered drugs.
  5. History of meningococcal infection, or has a first-degree relative with a history of meningococcal infection.
  6. Body temperature ≥ 38.0°Celcius at screening or check-in.
  7. Donation of whole blood from 3 months prior to first dosing or of plasma from 30 days before first dosing, or receipt of blood products within 6 months prior to first dosing.
  8. Has less than 1 bowel movement every 2 days or has a recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks prior to dosing.
  9. Has received radiolabeled substances or has been exposed to radiation sources within 12 months of dosing or is likely to receive radiation exposure or radioisotopes within 12 months of dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe.
  10. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days prior to dosing, whichever is longer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [14C]-ALXN2050
Participants will receive [14C]-ALXN2050.
Drug: [14C]-ALXN2050
A single dose of 200 milligrams (~85 microcuries) [14C]-ALXN2050 will be administered orally.
Other Names:
  • ACH-0145228 (formerly)
  • ALXN2050

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mass Balance Recovery In Urine And Feces After a Single Oral Dose Of [14C]-ALXN2050
Time Frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Mass balance will be assessed by evaluating total radioactivity recovery and the percent of the radioactive dose excreted in the urine and feces. Mass balance will be calculated as a sum of the percent of the total radioactivity recovered in urine and feces plus any radioactivity dose lost due to emesis (if any occurred) relative to the administered radioactivity dose.
Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Plasma Pharmacokinetics (PK) Of Total Radioactivity After A Single Oral Dose Of [14C]-ALXN2050: Area Under The Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf)
Time Frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-ALXN2050: Area Under The Concentration Versus Time Curve, From Time 0 To The Time Of The Last Measurable Concentration (AUC0-last)
Time Frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-ALXN2050: Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-ALXN2050: Time To Maximum Observed Plasma Concentration (Tmax)
Time Frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: AUC0-inf
Time Frame: Up to 168 hours postdose
Up to 168 hours postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: AUC0-last
Time Frame: Up to 168 hours postdose
Up to 168 hours postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: Cmax
Time Frame: Up to 168 hours postdose
Up to 168 hours postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: Tmax
Time Frame: Up to 168 hours postdose
Up to 168 hours postdose
Percentage Of Total Radioactivity Detected For Each ALXN2050 Metabolite in Plasma, Urine, And Feces
Time Frame: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
ALXN2050 metabolic profiling in plasma, urine, and feces will be performed in samples containing sufficient amounts of radioactivity. The percent of dose represented by each of the metabolites will be calculated using the radioactivity concentration equivalent data combined with the metabolic profiling data. The percentage of each identified metabolite to total radioactivity in plasma will be estimated based on plasma metabolic profiling data.
Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number Of Participants Receiving A Single Oral Administration Of [14C]-ALXN2050 With Treatment-emergent Adverse Events
Time Frame: Day 1 (after dosing) through follow-up (30 [+/- 2] days after dosing on Day 1
Day 1 (after dosing) through follow-up (30 [+/- 2] days after dosing on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexion Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALXN2050-HV-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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