Clinical trial · Interventional
A Food Effect Study of LP-168 Tablets in Healthy Subjects
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
NCT05917964CI-TRIAL-00069484completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LP-168 tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A (fasted-fed)
- description
- 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.
- interventionNames
- Drug: LP-168 tablet
- type
- EXPERIMENTAL
- label
- Cohort B (fed-fasted)
- description
- 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.
- interventionNames
- Drug: LP-168 tablet
Primary outcomes (4)
- measure
- PK Parameter AUC0-t
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.