TGRX-678 Pharmacokinetic Mass Balance

Shenzhen TargetRx

Status and phase

Not yet enrolling

Phase 1

Conditions

Chronic Myeloid Leukemia

Treatments

Drug: [14C]TGRX-678

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06986772

TGRX-678-1003

Details and patient eligibility

About

This is a pharmacokinetic study for [14C]TGRX-678 on mass balance to evaluate distribution, metabolism and excretion of TGRX-678, a tyrosine kinase inhibitor indicated for treatment of chronic myeloid leukemia.

Full description

This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-678 using the Carbon-14 labelled isotope of TGRX-678 compound. Safety and pharmacokinetic evaluation will also be conducted.

Enrollment

6 estimated patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adult males
age between 18 and 45 (both included) years old
body weight index between 19.0 and 26.0 kg/m2 (both included, and body weight not lower than 50 kg
can volunteeringly consent
can communicate well with investigators and complete study according to protocol requirements

Exclusion criteria

abnormal and of clinical significance results on physical exam, regular laboratory tests, thyroid function, anal check, chest x-ray, abdominal ultrasound check or 12-lead ECG
positive test results on hepatitis B surface antigen/ E antigen, hepatitis C antibody, HIV antigen/antibody or syphylus antibody
abnornal and of clinical significance results on eye exam
usage of any inducers or inhibitors for drug metabolism enzymes (especially CYP3A4) within 30 days of screening
usage of any prescriptional drug, OTC drug, herbal medicine, traditional Chinese medicine, or food supplements (i.e., vitamins, calcium) within 14 days of screening
history of any clinically significant serious diseases or any conditions that at investigator's discretion may affect study results
have condition that may affect drug absoption
received major surgery or with un-healed surgical wounds within 6 months of screening
have allergies to at least 2 substances or at investigator's discretion may be allergic to investigational drug or any excipients
have hemorrhoids; have history of or is having conditions that cause bloody feces, irritable bowel syndrome, or inflammatory bowel disease
habitutory constipation or diarrhea
alcohol abuse, or frequent use of alcohol within 6 months of screening
smoking of more than 5 cigarettes per day within 3 months of screening, or habitutory use of nicotine products and cannot quit during study
drug abuse, or use of soft drug (marajuana) within 3 months of screening, or use of hard drug (phenylamine or PCP type drugs) within 1 year of screening, or tested positive in urine drug test during screening
habitutory use of grape fruit juice, or overuse of tea, coffee or caffeinated drugs, and cannot quit during study
long-term occupational exposure to radioactive conditions, or have history of significant radioactive substance exposure or participated in clinical study using radioactive-labeled drugs within 1 year of current study
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; received blood donation within 1 months of study, 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