The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
Phase 1
Completed
- Conditions
- Chronic Hepatitis c
- Interventions
- Drug: HEC74647PA CapsuleDrug: placebo
- Registration Number
- NCT03673696
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Brief Summary
The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
- Detailed Description
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
- Able to comprehend and sign the ICF voluntarily prior to initiate the study;
- Able to complete the study according to the protocol;
- Between 18 and 45 years of age, inclusive, male subject should be no fertility needs;
- Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2, inclusive;
- Physical examination and vital signs without clinically significant abnormalities.
Exclusion Criteria
- Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
- Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
- Donated blood or massive blood loss within 3 months before screening (>450 mL）;
- Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
- Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 1 month prior to screening;
- Have participated in any clinical trial or taken any study drug within 3 months before dosing;
- Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 100 mg single dose placebo Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2). 200 mg single dose placebo Healthy subjects, receiving a single dose of 200 mg HEC74647PA capsule (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study. 600 mg single dose HEC74647PA Capsule Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2). 100 mg single dose HEC74647PA Capsule Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2). 200 mg multiple doses placebo Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days. 400 mg multiple doses HEC74647PA Capsule Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days. 400 mg single dose HEC74647PA Capsule Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2). 50 mg single dose placebo It includes two group, one group is pilot study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=2) . Another group is formal study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=8) or matching placebo (N=2). 400 mg single dose placebo Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2). 800 mg single dose placebo Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2). 50 mg single dose HEC74647PA Capsule It includes two group, one group is pilot study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=2) . Another group is formal study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=8) or matching placebo (N=2). 200 mg single dose HEC74647PA Capsule Healthy subjects, receiving a single dose of 200 mg HEC74647PA capsule (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study. 600 mg single dose placebo Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2). 800 mg single dose HEC74647PA Capsule Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2). 100 mg multiple doses HEC74647PA Capsule Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days. 200 mg multiple doses HEC74647PA Capsule Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days. 100 mg multiple doses placebo Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days. 400 mg multiple doses placebo Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
- Primary Outcome Measures
Name Time Method Adverse events of the single ascending-dose Baseline to day 6~13 To assess the tolerability after a single dose of HEC74647PA capsule
Adverse events of the multiple ascending-dose Baseline to day 12 To assess the tolerability after multiple doses of HEC74647PA capsule
Tmax Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing Time of the maximum observed plasma concentration
T1/2 Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing Terminal elimination half-life
Vz/F Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing Apparent volume of distribution
CL/F Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing Oral clearance
MRT Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing Mean Residence Time
AUC Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing Area under the plasma concentration-time curve (AUC)
Cmax Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing Maximum observed plasma concentration of HEC74647
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China