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Fosgonimeton

Phase 1

Undisclosed | Small molecule | Other |LeonaBio, Inc.|Trials Updated: Dec 22, 2022

Fosgonimeton target and mechanism

ModalitySmall molecule

Also known as [14C]-Fosgonimeton

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Fosgonimeton clinical trials

Fosgonimeton · 1 trial · 1 indication

Phase 1 1
NCT05511558A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)Healthy Volunteers
COMPLETED8 Analytics
PHASE1COMPLETED
A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Mass balance of total radioactivity from [14C]-Fosgonimeton
Samples collected pre-dose.

Total radioactivity recovery (fet1-t2)

Routes/rates of elimination of [14C]-Fosgonimeton
Samples collected pre-dose.

Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).

Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001
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
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
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
Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.

t1/2 will be determined from plasma samples.

Secondary Endpoints

Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration
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
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
Samples collected pre-dose and at predetermined timepoints up to 17 days post-dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dosing GroupEXPERIMENTALAll 8 subjects will receive a single dose of study drug

Interventions

NameTypeDescription
[14C]-FosgonimetonDRUGCarbon-14 Radiolabeled Fosgonimeton
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Eligibility Criteria

Age Range18 Years to 60 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Males, of any race, between 18 and 60 years of age, inclusive. 2. Body mass index between 18.0 and 32.0 kg/m2, inclusive. 3. In good health, determined by the investigator's discretion 4. Subjects and their partners will agree to use contraception during their participation 5...

Countries:United States
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Frequently asked questions about Fosgonimeton

What is Fosgonimeton?

Fosgonimeton is a small molecule drug candidate developed by LeonaBio, Inc. (ticker LONA). It is in Phase 1 clinical development, and its specific therapeutic indications have not been disclosed. The compound has been studied in a single completed Phase 1 trial involving healthy male volunteers.

Who makes Fosgonimeton?

Fosgonimeton is being developed by LeonaBio, Inc., which trades under the ticker symbol LONA. LeonaBio is the sponsor of the clinical program for Fosgonimeton.

What phase is Fosgonimeton in?

Fosgonimeton is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials at this time. The drug is investigational and has not been approved by the FDA.

What clinical trials is Fosgonimeton in?

Fosgonimeton has been evaluated in one completed Phase 1 trial, NCT05511558, titled "A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)." The trial enrolled 8 healthy male volunteers in the United States and was completed.

Is Fosgonimeton the same as [14C]-Fosgonimeton?

Yes, [14C]-Fosgonimeton is an alternative name for Fosgonimeton. The carbon-14 labeled version, [14C]-Fosgonimeton, was used in the Phase 1 trial NCT05511558 to study the absorption, metabolism, and excretion of the drug.