Chronic Myeloid Leukemia (CML)
Conditions
Keywords
Chronic Myeloid Leukemia, HQP1351
Brief summary
The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 30mg (100µCi) dose of \[14C\] HQP1351 given as a suspension. For further clinical development, human mass balance data are required to elucidate the absorption, metabolism, and excretion of HQP1351.
Interventions
DRUG[14C] HQP1351
Orally, single dose of 30mg
Sponsors
HealthQuest Pharma Inc.
Ascentage Pharma Group Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
A subject will be eligible for study participation if he meets the following criteria: 1. Healthy male volunteers between the ages of 18 to 50 years old, inclusive; 2. Body weight \>=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive); 3. Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant; 4. Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 1 year after discontinuing treatment with the investigational product. 5. Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.
Exclusion criteria
A subject will not be eligible for study participation if he meets any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radioactivity concentration of each blood and plasma sample | Day 1- Day 15 | Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample |
| Radioactivity concentration of each urine samples | Day 1- Day 15 | Use liquid scintillation counter to evaluate Radioactivity concentration of each urine sample |
| Radioactivity concentration of each feces samples | Day 1- Day 15 | Use liquid scintillation counter to evaluate Radioactivity concentration of each feces sample |
| Total recovery of radioactivity in urine and feces | Day 1- Day 15 | Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Day 1- Day 15 | According to CTCAE v5.0, the number and frequency of adverse events after a single dose of test drug were assessed. |
| Plasma drug concentrations | Day 1- Day 15 | To determine the plasma concentrations of HQP1351 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters |
Countries
China
Outcome results
None listed