TGRX-678 Phase I Oral Pharmacokinetic Study

NCT06697899 | Completed Phase 1

• 1 other identifier: TGRX-678-1002
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (9)

• Plasma Tmax

  Time to maximum concentration (Tmax) of TGRX-678 measured in plasma

  During Treatment period (Day 1 to Day 43)

• Plasma Tlag

  Time between drug administration to drug absorption (Tlag) as indicated by TGRX-678 plasma concentration

  During Treatment period (Day 1 to Day 43)

• Plasma Cmax

  Maximum concentration (Cmax) of TGRX-678 measured in plasma

  During Treatment period (Day 1 to Day 43)

• Plasma AUC(0-t)

  Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-678 as measured in plasma

  During Treatment period (Day 1 to Day 43)

• Plasma AUC(0-inf)

  Area Under drug concentration-time curve from time 0 to infinity for TGRX-678 as measured in plasma

  During Treatment period (Day 1 to Day 43)

• AUC(%Extrap)

  Calculated percentage of Area under curve for AUC(0-inf) that is from last measurable timepoint ot infinity, calculated based on TGRX-678 plasma concentration over time curve.

  During Treatment period (Day 1 to Day 43)

• Half Life (T1/2)

  Time for TGRX-678 to decrease from maximum plasma concentration to half of maximum plasma concentration

  During Treatment period (Day 1 to Day 43)

• Plasma volume of distribution (Vz/F)

  Apparent volume of distribution of TGRX-678 in plasma

  During Treatment period (Day 1 to Day 43)

• Plasma clearance (CL/F)

  Apparent clearance of TGRX-678 in plasma

  During Treatment period (Day 1 to Day 43)

Secondary Outcomes (1)

• Adverse Events (AE)

  Starting from consent signing and until end of Treatment period (Day 1 to Day 43)

Study Arms (3)

Fasting

EXPERIMENTAL

Participants take TGRX-678 under fasting state

Drug: TGRX-678

Low-fat Diet

EXPERIMENTAL

Participants take TGRX-678 after low-fat meal intake

Drug: TGRX-678

High-fat Diet

EXPERIMENTAL

Participants take TGRX-678 after high-fat meal intake

Drug: TGRX-678

Interventions

TGRX-678 DRUG

All participants are given TGRX-678 orally at 240 mg

Fasting; High-fat Diet; Low-fat Diet

Eligibility Criteria

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

You may qualify if:

• Healthy participants, male or female
• Age between 18 and 45 (both inclusive)
• Body Weight: male ≥ 50 kg, female ≥ 45 kg; Body Mass Index (BMI) between 19.0 and 26.0 kg/m\^2 (both inclusive)
• Signing informed concent at own will
• Able to communicate with researcher and able to complete study per protocol instruction

You may not qualify if:

• Clinically significant abnormal results in lab test, physical exam or 12-lead electrocardiogram (ECG) test
• Positive results for Hepatitis B, Hepatitis C, HIV or Syphilis
• QT interval elongation as indicated by 12-lead ECG test during screening period
• Use of any medication that could impact CYP3A4 enzyme activities within 30 days prior to Screening period
• Use of any medication within 14 days of first dose of the investigational drug
• Vaccinated within 30 days of first dose of the investigational drug, or planning to be vaccinated during study
• History of instrumental cardiovascular diseases
• Received major surgery within 6 months prior to Screening, or with surgical wounds not completely healed
• History of any severe disease or conditions that could affect study results per investigator's discretion
• History of allergic conditions or is allergic to components of the investigational drug
• Having conditions that could affect drug absorption or difficulties to swallow
• History of smoking of \>5 cigarettes per day within 3 months prior to screening, or cannot stop tabacco using during study
• History of alcohol abuse, or alcohol consumption of \>14 unit alcohol within 3 months prior to screening
• History of substance use, or tested positive for drug test during screening
• History of specific food (i.e., grapefruit, mango) consumption, or/and large tea/coffee/caffeinated drink/grapefruit product intake of \> 8 cups per day, within 2 weeks prior to first dose

Sponsors & Collaborators

• Shenzhen TargetRx, Inc.: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Li, MD

  Nanjing Drug Tower Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: November 24, 2024
• Primary Completion: January 6, 2025
• Study Completion: February 20, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)