An Open-Label PET/CT Imaging Study to Evaluate Brain Serotonin Transporter (SERT) Occupancy Following Single-Dose Administration of LG-0317 Tablets in Healthy Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorLinGang Laboratory

About this trial

The purpose of the study is to evaluate brain serotonin transporter (SERT) receptor occupancy (RO) following single oral doses of LG-0317 tablets in healthy male participants; and to explore the pharmacokinetic/pharmacodynamic (PK/PD) relationship between LG-0317 plasma concentrations and SERT occupancy..

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 19-28 kg/m2 inclusive.

The participant has normal results or abnormalities without clinical significance as judged by the investigator for vital signs, physical examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis), 12-lead electrocardiogram (ECG.

Fully understand the trial content, procedures, and possible adverse reactions; voluntarily participate and sign the informed consent form (ICF).

Able to communicate well with the study personnel, and understand and comply with the relevant requirements of the trial.

Disqualifiers

1) Allergic constitution, history of allergic diseases, or known allergy to the investigational product, its excipients, or related products.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cohort 1: LG-0317 20 mg

    Drug

    Subjects will receive single dose of LG-0317 tablets.

  • Cohort 1: LG-0317 40 mg

    Drug

    Subjects will receive single dose of LG-0317 tablets.

  • Cohort 1: LG-0317 80 mg

    Drug

    Subjects will receive single dose of LG-0317 tablets.

Treatment groups

12 Participants
are divided into 3 treatment groups
Group A: Cohort 1: LG-0317 20 mgExperimental treatment 1 intervention
Group B: Cohort 2: LG-0317 40 mgExperimental treatment 1 intervention
Group C: Cohort 3: LG-0317 80 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Receptor Occupancy: SERT occupancy in brain ROIs post single-dose of LG-0317 as measured by PET/CT.

Time frame
Day 1

Secondary outcomes

1

Pharmacokinetics: maximum plasma concentration (Cmax)

Time frame
Day 3
2

Pharmacokinetics: time to reach Cmax(Tmax)

Time frame
Day 3
3

Pharmacokinetics: area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t)

Time frame
Day 3
4

Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
Day 10

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

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