Healthy
Conditions
Keywords
Subjects
Brief summary
This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.
Interventions
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy. * Weight≥50 kg，19≤BMI≤28 kg/m2. * Platelet count is within normal range
Exclusion criteria
* History of clinically significant illness. * History of alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum plasma concentration (Cmax) of hetrombopag | 0h-120h | Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state |
| The area under the plasma concentration-time curve (AUC) of hetrombopag | 0h-120h | AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state |
| The accumulative excretion rate of hetrombopag and its metabolites in urine and feces | 0h-120h | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of platelet count | On day 2, 4, 6, 8,12, 14 and 16 |
| The number of volunteers with adverse events as a measure of safety and tolerability | up to Day 16 |
Countries
China
Outcome results
None listed