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

Primary Purpose

Chronic Hepatitis c

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
yimitasvir
placebo
Sponsored by
Sunshine Lake Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis c

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

30 mg single dose

100 mg single dose

200 mg single dose

400 mg single dose

600 mg single dose

800 mg single dose

1000 mg single dose

Arm Description

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Adverse events
To assess the safety and tolerability after a single dose of DAG181
Cmax
Maximum observed plasma concentration of DAG181
Tmax
Time of the maximum observed plasma concentration
AUC
Area under the plasma concentration-time curve (AUC)
T1/2
Terminal elimination half-life

Secondary Outcome Measures

Full Information

First Posted
February 9, 2018
Last Updated
March 8, 2018
Sponsor
Sunshine Lake Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03462173
Brief Title
The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 3, 2014 (Actual)
Primary Completion Date
January 30, 2015 (Actual)
Study Completion Date
January 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis c

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 30 mg yimitasvir(N=6) or placebo(N=2)
Arm Title
100 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 100 mg yimitasvir (N=6) or placebo(N=2)
Arm Title
200 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 200 mg yimitasvir (N=6) or placebo(N=2)
Arm Title
400 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 400 mg yimitasvir (N=6) or placebo(N=2)
Arm Title
600 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 600 mg yimitasvir (N=6) or placebo(N=2)
Arm Title
800 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 800 mg yimitasvir (N=6) or placebo(N=2)
Arm Title
1000 mg single dose
Arm Type
Experimental
Arm Description
Healthy subjects, receiving a single dose of 1000 mg yimitasvir (N=6) or placebo(N=2)
Intervention Type
Drug
Intervention Name(s)
yimitasvir
Other Intervention Name(s)
DAG181
Intervention Description
Capsule administered orally once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
DAG181 placebo
Intervention Description
Matching Placebo Capsule
Primary Outcome Measure Information:
Title
Adverse events
Description
To assess the safety and tolerability after a single dose of DAG181
Time Frame
Baseline to day 10
Title
Cmax
Description
Maximum observed plasma concentration of DAG181
Time Frame
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
Title
Tmax
Description
Time of the maximum observed plasma concentration
Time Frame
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
Title
AUC
Description
Area under the plasma concentration-time curve (AUC)
Time Frame
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
Title
T1/2
Description
Terminal elimination half-life
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yimin Cui, Doctor
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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