Clinical trial NCT03973632: Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions
Official title: A Phase I, Open-label, Single-center, Crossover Design of Food-effect Study of SH-1028 Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-04
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.

Detailed description: By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.

Eligibility criteria: Inclusion Criteria:

1. Healthy Subject with acceptable laboratory results.
2. BMI between 19 and 26; Weight between 50 and 80 kg
3. Not allowed to smoke or drink during the trial.
4. Subject should be willing to contracept during the study and until 6 months after completion of study.

Exclusion Criteria:

1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
2. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity
3. Addicted to smoking and drinking.
4. Hemorrhage over 200mL in 3 months before the trial.
5. Other conditions not suitable for trial, by judgement of investigator.

Primary outcomes:
measure: Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)
timeFrame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2(Each cycle is 4 days with a 3-days interval).
measure: Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration [AUC(0-t)]
timeFrame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).
measure: Pharmacokinetic of SH-1028 Tablets by assessment of time to Cmax (tmax)
timeFrame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).
Secondary outcomes:
measure: Adverse event（AE）rate and serious adverse event（SAE）rate
timeFrame: From signing of informed consent to ending of the trial, about 25 days.
measure: Pharmacokinetic of SH-1028 Tablets by assessment of maximum plasma concentration (Cmax)
timeFrame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
measure: Pharmacokinetic of SH-1028 Tablets by assessment of terminal rate constant (λz) [
timeFrame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
measure: Pharmacokinetic of SH-1028 Tablets by assessment of Terminal half life (t1/2）
timeFrame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
measure: Pharmacokinetic of SH-1028 Tablets by assessment of apparent plasma clearance (CL/F)
timeFrame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
measure: Pharmacokinetic of SH-1028 Tablets by assessment of apparent volume of distribution (Vz/F)
timeFrame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
measure: Pharmacokinetic of SH-1028 Tablets by assessment of Mean Residence Time（MRT）
timeFrame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
measure: Pharmacokinetic of SH-1028 Tablets by assessment of AUC[%Extrap obs],the rate of AUC(t-∞) to AUC
timeFrame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Other outcomes:
Locations:
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