Mass Balance Study of [14C] LPM3770164 in Healthy Participants

Sponsor
Luye Pharma Group Ltd.
Study ID
NCT07516899
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • [14C] LPM3770164 — DRUG
    The subjects are required to take 20 mg/150 µCi \[14C\] LPM3770164 tablet (s) in the fasted state with a total of approximately 240 mL of water to ensure completion within 5 minutes

Study Details

This is a phase 1, single-center, single-dose, open-label mass-balance study to evaluate radioactive recovery rate, radioactive PK characteristics, metabolite identification, and to observe the safety in healthy male subjects of \[14C\] LPM3770164.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: [14C] LPM3770164
    20 mg/150 µCi \[14C\] LPM3770164

Primary Outcome Measure

Recovery of total radioactivity in excreta (urine and feces) per collection period; [ Time Frame: within up to 40 days after dosing ]

Central Contacts

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