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

Chronic Hepatitis c Clinical Trial

Official title:

A Phase I, Randomized，Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Yimitasvir in Healthy Adults Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462173
• Other study ID #: PCD-DDAG181PA-13-001
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2018
• Last updated: March 8, 2018
• Start date: December 3, 2014
• Est. completion date: January 22, 2016

Study information

• Verified date: March 2018
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 22, 2016
• Est. primary completion date: January 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• yimitasvir
Capsule administered orally once daily
• placebo
Matching Placebo Capsule

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	To assess the safety and tolerability after a single dose of DAG181	Baseline to day 10
Primary	Cmax	Maximum observed plasma concentration of DAG181	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
Primary	Tmax	Time of the maximum observed plasma concentration	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
Primary	AUC	Area under the plasma concentration-time curve (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
Primary	T1/2	Terminal elimination half-life	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