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TGRX-326 Pharmacokinetic Mass Balance

Sponsored by Shenzhen TargetRx, Inc.

About this trial

Last updated a year ago

Study ID

TGRX-326-1004

Status

Not yet recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 45 Years
Male
Male

Trial Timing

Ended 8 months ago

What is this trial about?

This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.

What are the participation requirements?

Yes

Inclusion Criteria

- Healthy adult males

- Age between 18 and 45 years old (both limits included)

- Body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg

- Willing to consent

- Able to communicate with investigator and complete study according to study protocol

No

Exclusion Criteria

- Clinically significant results from comprehensive physical and clinical examinations

- Positive results on hepatitis, HIV or syphilis

- Clinically significant results from eye examination

- Usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening

- Usage of any prescription or non-prescription drug, Chinese herbal medicine or dietary supplements

- Presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement

- Presence of any condition that could affect drug absorption

- Reception of major surgery within 6 months before screening, or surgical wounds not completely healed

- Presence of allergic reactions or may be allergic to ingredients in the investigational drug

- Presence of hemorrhoids, or having history of or is having conditions that cause bloody feces

- Habitual congestion or diarrhea

- Alcohol abuse or excessive alcohol consumption within 6 months before screening

- Excessive smoking within 3 months before screening

- Substance abuse or positive results on urine substance test

- Habits of grapefruit juice consumption or excessive caffeinated drinks consumption

- History of long-term exposure under radiation; or significant radiation exposure 1 year before this study; or participation in other radioactive drug studies

- Having difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness

- Participation in any other clinical studies within 3 months before screening

- Reception of vaccine within 1 months before screening, or planning to be vaccinated during the study

- Planning to have children or donate sperms during the study and within 1 year after the study, or Not agreeing to take contraceptive measures during and within 1 year after study completion

- Blood donation or blood loss of > 400 ml within 3 months before screening; blood donation or blood loss of > 200 ml within 1 month before screening; reception of blood transfusion within 1 months before screening, or planning to donate blood within 3 months after study completion

- Having special dietary requirements and unable to follow the uniform dietary plan in the study

- Any conditions that the investigator deemed unfit for the study