TGRX-678 Phase I Oral Pharmacokinetic Study

May 15, 2025 updated by: Shenzhen TargetRx, Inc.

Food Effect on Pharmacokinetic Profile for TGRX-678 Tablet in Chinese Healthy Subject With Single Oral Administration

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is designed as single-center, single-dose, randomized, open-label and parallel-comparison to evaluate food effect on PK profile of TGRX-678 in healthy subjects. Safety and tolerability of the drug is also evaluated during study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Having special dietary requirement and cannot comply with food requirement of the study
  • Pregnant or breastfeeding female, or tested positive in pregnancy test
  • History of unprotected sexual activities within 1 month prior to screening
  • Having plans for pregnancy during the study and within 6 months after study completion; or not agreeing to take strict contraceptive measures during study and within 6 months after study completion
  • History of blood loss/ blood donation of ≥ 400 mL within 3 months prior to screening, or planning to donate blood within 1 month after study completion
  • Any reasons that is deemed unsuitable for study participation as determined by investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fasting
Participants take TGRX-678 under fasting state
Drug: TGRX-678
All participants are given TGRX-678 orally at 240 mg
Experimental: Low-fat Diet
Participants take TGRX-678 after low-fat meal intake
Drug: TGRX-678
All participants are given TGRX-678 orally at 240 mg
Experimental: High-fat Diet
Participants take TGRX-678 after high-fat meal intake
Drug: TGRX-678
All participants are given TGRX-678 orally at 240 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma Tmax
Time Frame: During Treatment period (Day 1 to Day 43)
Time to maximum concentration (Tmax) of TGRX-678 measured in plasma
During Treatment period (Day 1 to Day 43)
Plasma Tlag
Time Frame: During Treatment period (Day 1 to Day 43)
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
Time Frame: During Treatment period (Day 1 to Day 43)
Maximum concentration (Cmax) of TGRX-678 measured in plasma
During Treatment period (Day 1 to Day 43)
Plasma AUC(0-t)
Time Frame: During Treatment period (Day 1 to Day 43)
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)
Time Frame: During Treatment period (Day 1 to Day 43)
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)
Time Frame: During Treatment period (Day 1 to Day 43)
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 Frame: During Treatment period (Day 1 to Day 43)
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)
Time Frame: During Treatment period (Day 1 to Day 43)
Apparent volume of distribution of TGRX-678 in plasma
During Treatment period (Day 1 to Day 43)
Plasma clearance (CL/F)
Time Frame: During Treatment period (Day 1 to Day 43)
Apparent clearance of TGRX-678 in plasma
During Treatment period (Day 1 to Day 43)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events (AE)
Time Frame: Starting from consent signing and until end of Treatment period (Day 1 to Day 43)
To record adverse events to participants during study participation
Starting from consent signing and until end of Treatment period (Day 1 to Day 43)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen TargetRx, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juan Li, MD, Nanjing Drug Tower Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TGRX-678-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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