HealthyPhase 1NCT04609670
Study of Radiolabeled ALXN2050 in Healthy Adult Males
A Phase 1 study testing [14C]-ALXN2050 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]-ALXN2050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 23 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No clinically significant medical history, physical or neurological examination findings, screening clinical laboratory profiles, or electrocardiogram findings.
- 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.
- Non-sterile participants must agree to abstinence or use a highly effective method of contraception.
Who cannot join
- 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.
- 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.
- History or presence of seizures, head injury, or head trauma.
- History of procedures that could alter absorption or excretion of orally administered drugs.
- History of meningococcal infection, or has a first-degree relative with a history of meningococcal infection.
- Body temperature ≥ 38.0°Celcius at screening or check-in.
Show all 10Show fewer
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- [14C]-ALXN2050
- Keywords
- Mass Balance, ALXN2050, Factor D Inhibitor, Total Radioactivity, Absorption, Metabolism, Excretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-ALXN2050Drug
Also called ALXN2050, ACH-0145228 (formerly)
A single dose of 200 milligrams (~85 microcuries) [14C]-ALXN2050 will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-ALXN2050 | Experimental | Participants will receive [14C]-ALXN2050. Receives: Drug: [14C]-ALXN2050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance Recovery In Urine And Feces After a Single Oral Dose Of [14C]-ALXN2050
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Up to 168 hours postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: AUC0-last
Measured: Up to 168 hours postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: Cmax
Measured: Up to 168 hours postdose
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: Tmax
Measured: Up to 168 hours postdose
Percentage Of Total Radioactivity Detected For Each ALXN2050 Metabolite in Plasma, Urine, And Feces
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.
Measured: Up to 168 hours postdose or maximum of 504 hours for extended collection period postdose
Secondary outcomes (1)
Number Of Participants Receiving A Single Oral Administration Of [14C]-ALXN2050 With Treatment-emergent Adverse Events
Measured: Day 1 (after dosing) through follow-up (30 [+/- 2] days after dosing on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start12 Apr 2021
- Primary completion23 Aug 2021
- Study completion23 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609670
- Sponsor's protocol ID
- ALXN2050-HV-106
- Status last verified
- Jan 2023
- First submitted
- 26 Oct 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04609670
- Acronym / sponsor ID
- ALXN2050-HV-106
- Conditions
- Healthy
- Keywords
- Mass Balance, ALXN2050, Factor D Inhibitor, Total Radioactivity, Absorption, Metabolism, Excretion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-ALXN2050 | Experimental | Drug: [14C]-ALXN2050Participants will receive [14C]-ALXN2050. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No clinically significant medical history, physical or neurological examination findings, screening clinical laboratory profiles, or electrocardiogram findings.
- 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.
- Non-sterile participants must agree to abstinence or use a highly effective method of contraception.
Key exclusion criteria (10 listed)
- 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.
- 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.
- History or presence of seizures, head injury, or head trauma.
- History of procedures that could alter absorption or excretion of orally administered drugs.
- History of meningococcal infection, or has a first-degree relative with a history of meningococcal infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-ALXN2050Also: ALXN2050, ACH-0145228 (formerly)A single dose of 200 milligrams (~85 microcuries) [14C]-ALXN2050 will be administered orally. | Drug | [14C]-ALXN2050 |
Primary outcome
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.
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
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
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
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
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: AUC0-inf
Time frame: 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
Plasma PK Of ALXN2050 After A Single Oral Dose Of [14C]-ALXN2050: Cmax
Time frame: 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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-ALXN2050 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.