The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis c

Treatments: Drug: yimitasvir; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03462173

PCD-DDAG181PA-13-001

Details and patient eligibility

About

The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

32 participants in 7 patient groups

30 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 30 mg yimitasvir(N=6) or placebo(N=2)

Treatment:

Drug: placebo

Drug: yimitasvir

100 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 100 mg yimitasvir (N=6) or placebo(N=2)

Treatment:

Drug: placebo

Drug: yimitasvir

200 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 200 mg yimitasvir (N=6) or placebo(N=2)

Treatment:

Drug: placebo

Drug: yimitasvir

400 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 400 mg yimitasvir (N=6) or placebo(N=2)

Treatment:

Drug: placebo

Drug: yimitasvir

600 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 600 mg yimitasvir (N=6) or placebo(N=2)

Treatment:

Drug: placebo

Drug: yimitasvir

800 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 800 mg yimitasvir (N=6) or placebo(N=2)

Treatment:

Drug: placebo

Drug: yimitasvir

1000 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 1000 mg yimitasvir (N=6) or placebo(N=2)

Treatment:

Drug: placebo

Drug: yimitasvir