Healthy VolunteersPhase 1NCT05511558
A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)
A Phase 1 study testing [14C]-Fosgonimeton in people with Healthy Volunteers, run by LeonaBio at 1 site in United States.
Trial summary
This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of [14C]-Fosgonimeton Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-Fosgonimeton
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 26 Oct 2022
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, of any race, between 18 and 60 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by the investigator's discretion
- Subjects and their partners will agree to use contraception during their participation
- History of a minimum of 1 bowel movement per day.
Who cannot join
- Significant history or clinical manifestation of any relevant, significant medical disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Use or intend to use any nonprescription medications within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing.
Show all 9Show fewer
- Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months
- Poor peripheral venous access.
- Subjects with exposure to significant diagnostic or therapeutic radiation (e.g., serial x-ray, computed tomography scan, barium meal)
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017) Following a Single Subcutaneous Dose in Healthy Male Subjects
This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of [14C]-Fosgonimeton
Read the detailed description
This is a Phase 1, open-label, nonrandomized, single-dose study, designed to evaluate the absorption, metabolism, and excretion of [14C]-Fosgonimeton. Healthy male subjects will receive a single subcutaneous dose of [14C]-Fosgonimeton.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-Fosgonimeton
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-FosgonimetonDrug
Also called [14C]-ATH-1017
Carbon-14 Radiolabeled Fosgonimeton
| Study group | Role | What they receive |
|---|---|---|
| Dosing Group | Experimental | All 8 subjects will receive a single dose of study drug Receives: Drug: [14C]-Fosgonimeton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance of total radioactivity from [14C]-Fosgonimeton
Total radioactivity recovery (fet1-t2)
Measured: Samples collected pre-dose.
Mass balance of total radioactivity from [14C]-Fosgonimeton
Total radioactivity recovery (fet1-t2)
Measured: Samples collected up to 9 days post-dose.
Routes/rates of elimination of [14C]-Fosgonimeton
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
Measured: Samples collected pre-dose.
Routes/rates of elimination of [14C]-Fosgonimeton
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
Measured: Samples collected up to 9 days post-dose.
Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001
Cmax will be determined from plasma samples.
Measured: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Time to maximum observed plasma concentration (Tmax) of ATH-1017/ATH-1001
Tmax will be determined from plasma samples
Measured: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001
AUC will be determined from plasma samples.
Measured: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Half-life (t1/2) of ATH-1017/ATH-1001
t1/2 will be determined from plasma samples.
Measured: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Secondary outcomes (3)
Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration
Quantification of ATH-1017 major metabolites in plasma and excreta.
Measured: Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose
The chemical structure of major metabolites in plasma, urine, and feces after [14C]-Fosgonimeton administration
Identification of ATH-1017 major metabolites in plasma (>10% relative total drug-related exposure) and excreta (>10% of excreted dose)
Measured: Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose
Incidence and severity of adverse events (safety and tolerability) of [14C]-Fosgonimeton when administered to healthy subjects
Incidence and severity of adverse events
Measured: Samples collected pre-dose and at predetermined timepoints up to 17 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start13 Jul 2022
- Primary completion18 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- LeonaBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc, Alturas Analytics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511558
- Sponsor's protocol ID
- ATH-1017-0102
- Status last verified
- Dec 2022
- First submitted
- 15 Aug 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017) Following a Single Subcutaneous Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05511558
- Acronym / sponsor ID
- ATH-1017-0102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- LeonaBioIndustry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc, Alturas Analytics, Inc.
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 23 Aug 2022 (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 a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of [14C]-Fosgonimeton
Detailed description
This is a Phase 1, open-label, nonrandomized, single-dose study, designed to evaluate the absorption, metabolism, and excretion of [14C]-Fosgonimeton. Healthy male subjects will receive a single subcutaneous dose of [14C]-Fosgonimeton.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dosing Group | Experimental | Drug: [14C]-FosgonimetonAll 8 subjects will receive a single dose of study drug |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males, of any race, between 18 and 60 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by the investigator's discretion
- Subjects and their partners will agree to use contraception during their participation
- History of a minimum of 1 bowel movement per day.
Key exclusion criteria (9 listed)
- Significant history or clinical manifestation of any relevant, significant medical disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Use or intend to use any nonprescription medications within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
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]-FosgonimetonAlso: [14C]-ATH-1017Carbon-14 Radiolabeled Fosgonimeton | Drug | Dosing Group |
Primary outcome
Mass balance of total radioactivity from [14C]-Fosgonimeton
Time frame: Samples collected pre-dose.
Total radioactivity recovery (fet1-t2)
Mass balance of total radioactivity from [14C]-Fosgonimeton
Time frame: Samples collected up to 9 days post-dose.
Total radioactivity recovery (fet1-t2)
Routes/rates of elimination of [14C]-Fosgonimeton
Time frame: Samples collected pre-dose.
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
Routes/rates of elimination of [14C]-Fosgonimeton
Time frame: Samples collected up to 9 days post-dose.
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001
Time frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Cmax will be determined from plasma samples.
Time to maximum observed plasma concentration (Tmax) of ATH-1017/ATH-1001
Time frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Tmax will be determined from plasma samples
Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001
Time frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
AUC will be determined from plasma samples.
Half-life (t1/2) of ATH-1017/ATH-1001
Time frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
t1/2 will be determined from plasma samples.
3 secondary outcomes
Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration
Time frame: Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose
The chemical structure of major metabolites in plasma, urine, and feces after [14C]-Fosgonimeton administration
Time frame: Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose
Incidence and severity of adverse events (safety and tolerability) of [14C]-Fosgonimeton when administered to healthy subjects
Time frame: Samples collected pre-dose and at predetermined timepoints up to 17 days post-dose
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 22 Dec 2022.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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]-Fosgonimeton in people with Healthy Volunteers, run by LeonaBio 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 5 inclusion and 9 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 22 Dec 2022. 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 of total radioactivity from [14C]-Fosgonimeton (time frame: Samples collected pre-dose.). The study lists 8 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 22 Dec 2022.