A Food Effect Study of LP-168 Tablets in Healthy Subjects

NCT05917964 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: LP-168-CN103
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, two-period, two-sequence two-treatment crossover design food effect study to evaluate the pharmacokinetic profile of LP-168 tablets in healthy subjects after single oral administration under fasted and fed conditions

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (4)

• PK Parameter AUC0-t

  PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time of The Last Quantifiable Concentration Of LP-168

  Up to 72 hours post last dose

• PK Parameter AUC0-∞

  PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time of Intersection of the extrapolated concentration-time curve and the time-axis Of LP-168 PK curve

  Up to 72 hours post last dose

• PK Parameter Cmax

  Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration of LP-168

  Up to 72 hours post last dose

• PK Parameter Tmax

  PK As Assessed By Time To Maximum Observed Plasma Concentration of LP-168

  Up to 72 hours post last dose

Secondary Outcomes (2)

• Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0

  From the first dose of the study drug to 4 days after last dose]

• Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0

  From the first dose of the study drug to 4 days after last dose]

Study Arms (2)

Cohort A (fasted-fed)

EXPERIMENTAL

Cohort A was administered once in Cycle 1 Day1 under fasted condition and once in Cycle 2 Day1 (i.e., Day8 after Cycle 1 administration) under fed condition for a total of 2 doses.

Drug: LP-168 tablet

Cohort B (fed-fasted)

EXPERIMENTAL

Cohort B was administered once in Cycle 1 Day 1 under fed condition and once in Cycle 2 Day 1 (i.e., D8 after Cycle 1 administration) under fasted conditions for a total of 2 doses.

Drug: LP-168 tablet

Interventions

LP-168 tablet DRUG

LP-168 is a small molecule kinase inhibitor that is administered once daily via oral administration

Also known as: NWP-775

Cohort A (fasted-fed); Cohort B (fed-fasted)

Eligibility Criteria

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

You may qualify if:

• Subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer
• Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose
• Male and female healthy subjects aged 18 to 55 years old
• Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg
• Subjects able to understand and comply with study requirements
• Willing to sign the informed consent

You may not qualify if:

• Abnormal vital signs, physical examination or laboratory tests with clinical significance
• Abnormal ECG or echocardiography with clinical significance
• Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive.
• Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug
• Subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug
• Subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug
• Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion
• Female subjects are breastfeeding or pregnant
• Subjects who have a history of drug/ alcohol/ tobacco abuse
• Subjects who have had a blood donation or massive blood loss within three months before screening; or had surgery within six months before screening
• Subjects who have participated in other clinical trial within three months before screening
• Subjects have special dietary requirements or cannot tolerate a standard meal

Sponsors & Collaborators

• Guangzhou Lupeng Pharmaceutical Company LTD.: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Honggang Lou, MS

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: June 21, 2023
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)