The Mass Balance Study of LP-168 in Healthy Subjects

NCT06126861 | Completed Phase 1 FDA Drug

• 1 other identifier: LP-168-CN104
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption characteristics, as well as to evaluate the metabolism and elimination pathways after a single oral dose of 150mg, 100μCi \[14C\]LP-168 in healthy subjects.

Conditions

Clinical Pharmacology

Outcome Measures

Primary Outcomes (3)

• Radioactivity concentration of blood and plasma sample

  Use liquid scintillation counter to evaluate Radioactivity concentration of each sample

  Day 1- Day 8

• Radioactivity concentration of urine and feces sample

  Use liquid scintillation counter to evaluate Radioactivity concentration of each sample

  Day 1- Day 15

• Number of metabolites and its proportion in plasma, urine and feces.

  To study the metabolite profiling

  Day 1- Day 15

Secondary Outcomes (2)

• Plasma LP-168/Major Metabolic concentrations

  Day 1- Day 8

• Treatment emergent adverse events as assessed by CTCAE 5.0

  Day 1- Day 15

Study Arms (1)

[14C]LP-168

EXPERIMENTAL

Using 14C-labeled LP-168 as a marker to investigate the absorption characteristic, as well as to evaluate the metabolism and elimination pathways in healthy subjects

Drug: [14C]LP-168

Interventions

[14C]LP-168 DRUG

single dose of 150 mg/100 μCi \[14C\] LP-168, orally suspension at fasted state

[14C]LP-168

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects
• Aged 18-45 (including the boundary value);
• Body weight over 50 kg, the body mass index (BMI) is between 19 and 26 kg/m2 (including the boundary value);
• Subjects must sign the informed consent form voluntarily;
• Agree to abide the requirements of the study protocol, willing to communicate with the study doctor.

You may not qualify if:

• After a comprehensive physical examination, vital signs, laboratory tests and other examinations are abnormal and have clinical significance;
• Hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen/antibody combined test (HIV-Ag/Ab) and Treponema pallidum antibody test positive;
• Subject with clinically significant abnormalities on ophthalmologic examination (slit lamp, intraocular pressure and fundus photography)
• Subject who have used any drug that inhibits or induces hepatic drug metabolizing enzymes or transporters during the screening period and within the previous 28 days;
• Subject who have taken any medication with inhibition gastric acid secretion during the screening period and within the previous 28 days
• Subject who have taken any anti-gastric acid medication during the screening period and within the previous 28 days
• Subject who have used any systemic medication during the screening period and within the previous 14 days
• Subject with a history of any clinically serious illness or disease or condition that, in the opinion of the investigator, may affect the results of the trial
• Subject with any condition that may affect the absorption of the drug
• Subject with history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, or symptoms of QT prolongation syndrome or family history of these syndrome.
• Subject with major surgery during the screening period and within the previous 6 months or surgical incisions that have not fully healed
• Subject with allergies, such as a known history of allergy to two or more substances
• Subject with hemorrhoids or perianal disease with regular or ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease
• Subject with habitual constipation or diarrhea
• Subject with alcohol abuse or regular use of alcohol in the 6 months prior to the screening period

Sponsors & Collaborators

• Guangzhou Lupeng Pharmaceutical Company LTD.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Study Officials

• Liyan Miao, MD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: December 25, 2023
• Primary Completion: February 2, 2024
• Study Completion: March 13, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)