Solid Tumor
Conditions
Brief summary
An open-label, randomized, single-dose, two-way crossover bioequivalence study to compare two strengths (10 mg and 20 mg) of IMP4297 capsules in healthy Chinese subjects under fed condition
Detailed description
An open-label, randomized, single-dose, two-way crossover bioequivalence study is designed to determine whether single oral dose of IMP4297 capsules 100 mg (5 × 20 mg strength) and IMP4297 capsules 100 mg (10 × 10 mg strength) are bioequivalent in healthy Chinese male subjects under fed condition. 36 subjects (at least 30 completed) are planned to be enrolled.
Interventions
DRUGIMP4297(20mg)
Single oral dose of IMP4297 administered under fasting conditions 5\*20 mg capsules in first intervention period and 10\*10 mg capsules in second intervention period (after washout period: at least 7 days)
DRUGIMP4297(10mg)
Single oral dose of IMP4297 administered under fasting conditions 10\*10 mg capsules in first intervention period and 5\*20 mg capsules in second intervention period (after washout period: at least 7 days)
Sponsors
Impact Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for the study: 1. The subject fully understands the objective, nature, method of the trial and possible adverse reactions, voluntarily acts as a subject, signs the informed consent form before any study procedure, and ensures that any procedure is performed by himself/herself. 2. Healthy Chinese male subjects aged 18 to 55 years (inclusive) at Screening. 3. Body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive); body weight ≥ 50.0 kg. 4. Subject is able to communicate well with the Investigator and understands and adheres to the requirements of the study.
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0-72 hours | Maximum concentration. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose, before meal) and 1 hour, 2 hour, 3 hour, 4 hour, 4.5 hour, 5 hour, 5.5 hour, 6 hour, 7 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection. |
| AUC0-last | 0-72 hours | Area under the drug concentration-time curve from time 0 to the last time with quantifiable concentration. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose, before meal) and 1 hour, 2 hour, 3 hour, 4 hour, 4.5 hour, 5 hour, 5.5 hour, 6 hour, 7 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection. |
| AUC0-inf | 0-72 hours | Area under the curve from time 0 to infinity. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose, before meal) and 1 hour, 2 hour, 3 hour, 4 hour, 4.5 hour, 5 hour, 5.5 hour, 6 hour, 7 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection. |
Countries
China
Outcome results
None listed