Human Mass Balance Study of AJM300: A Clinical Pharmacology Study to Investigate the Absorption, Metabolism, and Excretion of 14C-AJM300 after a Single Oral Dose in Healthy Adult Male Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224740

Enrollment

Registered

2019-06-21

Start date

2019-07-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult subjects

Interventions

investigational material(s) Generic name etc : AJM300 INN of investigational material : Carotegrast Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration fo

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - A BMI of >=18.5 to <25.0 kg/m2 - Deemed by the investigator or subinvestigator to have no clinically relevant abnormalities based on medical examination findings, vital signs, electrocardiogram, and laboratory tests and having no problems participating in this clinical study - Able to consent in writing to participate in this clinical study based on their own free will and to comply with the requirements of this study

Exclusion criteria

Exclusion criteria: Main exclusion criteria - Intake of a supplement containing garlic as the main ingredient within 6 weeks before administration of the investigational product - Intake of grapefruit, grapefruit juice, or food containing grapefruit components within 8 days before administration of 14C-AJM300 - Intake of St. John's wort or food containing its ingredients within 15 days before administration of 14C-AJM300 - A white blood cell count of 3000/micro-L or less in the laboratory tests at screening or on the day of admission or the day of dosing in Part 2 - A medical history, within 1 year before administration of 14C-AJM300, of or an ongoing serious infection - Any central nervous system symptoms - Receiving any dose of radioisotope-labeled substance or exposure to a large amount of radioactivity within 1 year before administration of 14C-AJM300 - Occupational exposure to radiation within 1 year before administration of 14C-AJM300

Design outcomes

Primary

Measure	Time frame
pharmacokinetics - Total 14C radioactivity: Whole blood and plasma radioactivity concentrations, and urinary and fecal excretion rates of radioactivity - Plasma drug concentrations: AJM300 and AJM300 metabolites - Urinary drug concentrations (excretion rates): AJM300 and AJM300 metabolites - Pharmacokinetic parameters - Plasma, urinary, and fecal metabolite profiles	—

Secondary

Measure	Time frame
safety - Physical examination - Vital signs - Electrocardiogram (ECG) (standard 12-lead ECG) - Laboratory tests - Adverse events	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026