Health TrialsbyHealthPanel

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

ConditionHuntington Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorLuye Pharma Group Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult Chinese males;

Age at informed consent: 18-45 years (including boundary value);

Body mass index (BMI) range of 19-26 kg/m2 (including the boundary value), and body weight of not less than 50 kg;

There is no plan to have children or donate sperm within 1 year after the participant signs the informed consent form and the participant voluntarily takes strict contraceptive measures within 1 year after signing the informed consent form and completing the trial;

Disqualifiers

Abnormal and clinically significant vital signs, physical examination, chest X-ray (anteroposterior), ophthalmic examination, anal digital examination and abdominal B ultrasound examination;

QTcF interval > 450 ms in men; or other abnormalities are clinically significant in the judgment of the investigator;

Abnormal tests of hepatitis B surface antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), treponema pallidum antibody and human immunodeficiency virus antibody are clinically significant at the investigator's discretion;

Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicine, food supplements within 4 weeks prior to screening;

Trial design

Design model

Single group

Treatments tested in this trial

  • [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

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: [14C] LPM3770164Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recovery of total radioactivity in excreta (urine and feces) per collection period;

Time frame
within up to 40 days after dosing
2

Cumulative recovery of total radioactivity in excreta (urine and feces)

Time frame
within up to 40 days after dosing
3

Percentage of parent drug and its metabolites in plasma to total radioactivity exposure (% AUC) in human plasma

Time frame
within up to 40 days after dosing
4

Percentage of parent drug and its metabolites in urine and feces to administered dose (% administered dose)

Time frame
within up to 40 days after dosing

Secondary outcomes

1

Treatment-emergent adverse event

Time frame
From baseline to 40 days after doing

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luye Pharma Group Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: