The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects
- Registration Number
- NCT03462173
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Brief Summary
The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects.
- Detailed Description
This was a Randomized，Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Yimitasvir in Healthy Adults Subjects
A total of 56 healthy subjects were divided into 7 groups, with each group consisting of 8 subjects. Six of the subjects received the investigational drug, and two received placebo. All of the subjects received a single dose.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- Male or female, overall healthy subjects;
- Between 18 and 45 years of age, inclusive, similar ages;
- Body weight should be≥50 kg; Body Mass Index (BMI) is between 19 and 25 kg/m2, inclusive, similar body weights;
- Able to comprehend and sign the ICF voluntarily prior to initiate the study;
- Able to communicate well with the investigator and complete the study according to the protocol.
Exclusion Criteria
- Pregnant or nursing female, or plan for pregnancy within 6 months;
- Female with positive urine pregnancy test results;
- Positive test results for HBsAg, anti-HCV Ab, anti-HIV Ab or syphilis;
- Have taken any drug inhibiting gastric acid secretion within 1 month prior to study drug administration, such as: H2 receptor antagonists (eg: Cimetidine, Ranitidine, Famotidine, Nizatidine and Roxatidine); Proton pump inhibitors (eg: Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole and Esomeprazole); cholinoceptor blocking drugs (eg: Atropine and Pirenzepine);
- History of immune system disease (such as thymus disease);
- Have undergone major surgery within 6 months before enrollment;
- History of tumor;
- Drink frequently within 6 months prior to study drug administration, namely alcohol consumption are more than 20 grams per day;
- Smokers, who smoke more than 1 cigarettes/day within 3 months before the study;
- Participated in any clinical trial within 3 months prior to the study;
- Cannot be tolerant to oral drugs.
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 yimitasvir (N=6) or placebo(N=2) 30 mg single dose yimitasvir Healthy subjects, receiving a single dose of 30 mg yimitasvir(N=6) or placebo(N=2) 600 mg single dose yimitasvir Healthy subjects, receiving a single dose of 600 mg yimitasvir (N=6) or placebo(N=2) 1000 mg single dose placebo Healthy subjects, receiving a single dose of 1000 mg yimitasvir (N=6) or placebo(N=2) 30 mg single dose placebo Healthy subjects, receiving a single dose of 30 mg yimitasvir(N=6) or placebo(N=2) 400 mg single dose yimitasvir Healthy subjects, receiving a single dose of 400 mg yimitasvir (N=6) or placebo(N=2) 600 mg single dose placebo Healthy subjects, receiving a single dose of 600 mg yimitasvir (N=6) or placebo(N=2) 800 mg single dose yimitasvir Healthy subjects, receiving a single dose of 800 mg yimitasvir (N=6) or placebo(N=2) 400 mg single dose placebo Healthy subjects, receiving a single dose of 400 mg yimitasvir (N=6) or placebo(N=2) 200 mg single dose placebo Healthy subjects, receiving a single dose of 200 mg yimitasvir (N=6) or placebo(N=2) 800 mg single dose placebo Healthy subjects, receiving a single dose of 800 mg yimitasvir (N=6) or placebo(N=2) 100 mg single dose yimitasvir Healthy subjects, receiving a single dose of 100 mg yimitasvir (N=6) or placebo(N=2) 200 mg single dose yimitasvir Healthy subjects, receiving a single dose of 200 mg yimitasvir (N=6) or placebo(N=2) 1000 mg single dose yimitasvir Healthy subjects, receiving a single dose of 1000 mg yimitasvir (N=6) or placebo(N=2)
- Primary Outcome Measures
Name Time Method Adverse events Baseline to day 10 To assess the safety and tolerability after a single dose of DAG181
Cmax Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing Maximum observed plasma concentration of DAG181
Tmax Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing Time of the maximum observed plasma concentration
AUC Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing Area under the plasma concentration-time curve (AUC)
T1/2 Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing Terminal elimination half-life
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China