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Non Small Cell Lung CancerPhase 1NCT06294561

TGRX-326 Pharmacokinetic Drug Interaction

A Phase 1 study testing Itraconazole+TGRX-326 and Efavirenz+TGRX-326 in people with Non Small Cell Lung Cancer, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitor/inducer drugs on pharmacokinetic profiles of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Itraconazole+TGRX-326 and Efavirenz+TGRX-326
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
4 Mar 2024to 6 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy subject; male or female
  • Age between 18 and 45 (inclusive)
  • body mass index (BMI) between 19.0 and 26.0 (inclusive)
  • agree to consent
  • able to communicate with investigator well and complete the study according to study protocol

Who cannot join

  • abnormal and clinically significant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.)
  • any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody
  • prolongation in QT interval
  • use of substance that affects CYP3A4 enzyme activity with 30 days before screening
  • use of any drug within 14 days of test article administration
  • use of any investigational drug or participation of any clinical study within 3 months before screening
Show all 21Show fewer
  • vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period
  • history of cardiovascular diseases
  • history of mental conditions including depression, aggressive behaviours, epilepsy, etc.
  • history of major surgery within 6 months before screen, or have unhealed surgical wounds.
  • any clinically significant conditions that investigator believes could affect study outcomes
  • history of allergic reactions, or allergic to any components to the study drugs, or have food allergy/special requirement for food that forbids the subject to follow food requirements for the study
  • daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study
  • history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or alcohol breath test of > 0.0 mg/dl at screening
  • history of substance abuse, or positive drug results at screening
  • history of certain food intake 2 weeks before screening, and/or use of more than 8 cups of tea/coffee/grapefruit juice
  • positive pregnancy test results, or pregnant/breast-feeding females
  • history of unprotected sexual activities within 1 month before screening
  • have plans for child bearing during study period and for 6 months after study, or disagree to take contraceptive measures during study period and for 6 months after study
  • history of blood donation or blood loss within 3 months before screening, or have plans to donate blood within 1 month after the study
  • any reasons that is deemed unsuitable for study participation as determined by investigator

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing Drug Tower Hospital

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: An Open-label, Two-cycle, Single Sequence, Self-controlled Study Evaluating Effects of Oral Itraconazole or Efavirenz on Pharmacokinetic Profiles of TGRX-326

This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitor/inducer drugs on pharmacokinetic profiles of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.

Read the detailed description

This study is designed as an open-label, single sequence, self-controlled study. The study will be conducted for 2 cycles, 10 days per cycle. Itraconazole, a CYP3A inhibitor, and Efavirenz, a CYP3A inducer, will be administrated orally with TGRX-326 to evaluate the effect of these drugs on the pharmacokinetic profiles of TGRX-326. Pharmacokinetic parameters will be evaluated as primary endpoints. Safety evaluation will also be conducted.

Being tested
Itraconazole+TGRX-326, Efavirenz+TGRX-326
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Itraconazole+TGRX-326Drug

    healthy subjects will be given TGRX-326 60 mg orally on Day 1, and Itraconazole 200 mg with TGRX-326 60 mg orally on day 11

  • Efavirenz+TGRX-326Drug

    healthy subjects will be given TGRX-326 60 mg orally on Day 1, and Efavirenz 600 mg with TGRX-326 60 mg orally on day 20

Study groups in NCT06294561
Study groupRoleWhat they receive
ItraconazoleExperimentalhealthy subjects will be given Itraconazole 200 mg orally with TGRX-326 60 mg
Receives: Drug: Itraconazole+TGRX-326
EfavirenzExperimentalhealthy subjects will be given Efavirenz 600 mg orally with TGRX-326 60 mg
Receives: Drug: Efavirenz+TGRX-326

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma Tmax

    Time to maximum concentration of TGRX-326 measured in plasma

    Measured: Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

  2. Plasma Cmax

    Maximum concentration of TGRX-326 measured in plasma

    Measured: Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

  3. Plasma AUC(0-t)

    Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-326 as measured in plasma

    Measured: Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

  4. Plasma AUC(0-inf)

    Area Under drug concentration-time curve from time 0 to infinity for TGRX-326 as measured in plasma

    Measured: Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

  5. T1/2

    Plasma half-life of TGRX-326

    Measured: Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

  6. Plasma volume of distribution (Vz/F)

    Apparent volume of distribution of TGRX-326 in plasma

    Measured: Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

  7. Plasma clearance (CL/F)

    Apparent clearance of TGRX-326 in plasma

    Measured: Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

Secondary outcomes (2)

  1. Adverse events/serious adverse events

    to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)

    Measured: through completion of the study, an average of 1 month

  2. Corrected QT Interval

    Corrected QT Interval (QTc) as measured by 12-lead electrocardiogram

    Measured: At screening; Itraconazole group: Day 1, Days 2-5, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Day 20 and Day 25 (or last day of dosing)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start4 Mar 2024
  3. Primary completion6 May 2024
  4. Study completion6 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06294561
Sponsor's protocol ID
TGRX-326-1003
Status last verified
Jun 2024
First submitted
28 Feb 2024
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Itraconazole+TGRX-326 and Efavirenz+TGRX-326 in people with Non Small Cell Lung Cancer, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Tmax (time frame: Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06294561.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

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