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

NCT ID: NCT03462173

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-03
• Study Completion Date: 2016-01-22

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.

Conditions

Chronic Hepatitis c

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

30 mg single dose

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

Group Type: EXPERIMENTAL

yimitasvir

Intervention Type: DRUG

Capsule administered orally once daily

placebo

Intervention Type: DRUG

Matching Placebo Capsule

100 mg single dose

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

Group Type: EXPERIMENTAL

yimitasvir

Intervention Type: DRUG

Capsule administered orally once daily

placebo

Intervention Type: DRUG

Matching Placebo Capsule

200 mg single dose

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

Group Type: EXPERIMENTAL

yimitasvir

Intervention Type: DRUG

Capsule administered orally once daily

placebo

Intervention Type: DRUG

Matching Placebo Capsule

400 mg single dose

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

Group Type: EXPERIMENTAL

yimitasvir

Intervention Type: DRUG

Capsule administered orally once daily

placebo

Intervention Type: DRUG

Matching Placebo Capsule

600 mg single dose

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

Group Type: EXPERIMENTAL

yimitasvir

Intervention Type: DRUG

Capsule administered orally once daily

placebo

Intervention Type: DRUG

Matching Placebo Capsule

800 mg single dose

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

Group Type: EXPERIMENTAL

yimitasvir

Intervention Type: DRUG

Capsule administered orally once daily

placebo

Intervention Type: DRUG

Matching Placebo Capsule

1000 mg single dose

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

Group Type: EXPERIMENTAL

yimitasvir

Intervention Type: DRUG

Capsule administered orally once daily

placebo

Intervention Type: DRUG

Matching Placebo Capsule

Interventions

yimitasvir

Capsule administered orally once daily

Intervention Type: DRUG

placebo

Matching Placebo Capsule

Intervention Type: DRUG

Other Intervention Names

DAG181; DAG181 placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yimin Cui, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PCD-DDAG181PA-13-001

Identifier Type: -

Identifier Source: org_study_id