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A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

Primary Purpose

Chronic Hepatitis c

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ravidasvir 50mg
Ravidasvir 200mg
Sponsored by
Ascletis Pharmaceuticals 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:

  • Age between 18-45 years old;
  • Male body weight not less than 50kg; Female body weight not less than 45kg; BMI in the range of 19~24kg/m2
  • Healthy men or women based on history, physical examination, laboratory examination and ECG.
  • no plan of pregnancy in at least six months, and willing to take effective measures to prevent contraception from the first time when the drug is administered till the last time the drug is administered within 30 days.
  • Female has negative pregnancy tests at the screening stage.
  • Voluntary to sign the informed consent.

Exclusion Criteria:

  • Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors.
  • Has a history of drug or food allergy.
  • Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening.
  • Laboratory tests out of normal range and judged by the investigators as clinically significant.
  • Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery.
  • Pregnant, lactating women and people who unwilling to take effective measures to prevent contraception.
  • People who consumed pomelo, apple or orange and foods or drinks containing their extracted ingredients within 3 days of taking the drug.
  • Any prescription or over-the-counter medications, herbs, and vitamins are required to be taken prior to or within the first month of taking the drug.
  • Selected within the first 6 months of smoking, alcohol, drug abuse or history of drug abuse.
  • Selected within the first 3 months had blood loss or blood donation of 200ml.
  • Participate in other clinical trials within the first 3 months of the study and received other study drug treatment.
  • In addition to the above, the investigators judged not suitable for participating in this clinical trial.

Sites / Locations

  • First Hospital of Zhejiang Province

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

GROUP 1

GROUP 2

GROUP 3

GROUP 4

GROUP 5

GROUP 6

Arm Description

1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 19th to 25th day： Ravidasvir 200mg administered orally once daily.

1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.

1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.

1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: Ravidasvir 200mg administered orally once daily; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.

1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.

1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.

Outcomes

Primary Outcome Measures

Peak plasma concentration (Cmax)
Pharmacokinetics (blood draws, pre- and post-dose)
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics (blood draws, pre- and post-dose)

Secondary Outcome Measures

Full Information

First Posted
January 10, 2018
Last Updated
June 27, 2018
Sponsor
Ascletis Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03430830
Brief Title
A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China
Official Title
A Randomized, Open, Three-dose (100 mg, 200 mg and 300 mg) Duplicate Bifunctional Crossover and Fixed 200mg Continuous Dose Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
April 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascletis Pharmaceuticals 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 purpose of this study is to evaluate the pharmacokinetics and safety of ASC16 after 3-single dose(50mg、100mg、200mg) or fixed continuous dose(200mg) in healthy volunteers.

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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1
Arm Type
Experimental
Arm Description
1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 19th to 25th day： Ravidasvir 200mg administered orally once daily.
Arm Title
GROUP 2
Arm Type
Experimental
Arm Description
1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Arm Title
GROUP 3
Arm Type
Experimental
Arm Description
1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Arm Title
GROUP 4
Arm Type
Experimental
Arm Description
1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: Ravidasvir 200mg administered orally once daily; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Arm Title
GROUP 5
Arm Type
Experimental
Arm Description
1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Arm Title
GROUP 6
Arm Type
Experimental
Arm Description
1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Ravidasvir 50mg
Other Intervention Name(s)
ASC16
Intervention Description
50mg, Tablet
Intervention Type
Drug
Intervention Name(s)
Ravidasvir 200mg
Other Intervention Name(s)
ASC16
Intervention Description
200mg, Tablet
Primary Outcome Measure Information:
Title
Peak plasma concentration (Cmax)
Description
Pharmacokinetics (blood draws, pre- and post-dose)
Time Frame
27 days
Title
Area under the plasma concentration versus time curve (AUC)
Description
Pharmacokinetics (blood draws, pre- and post-dose)
Time Frame
27 days

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: Age between 18-45 years old; Male body weight not less than 50kg; Female body weight not less than 45kg; BMI in the range of 19~24kg/m2 Healthy men or women based on history, physical examination, laboratory examination and ECG. no plan of pregnancy in at least six months, and willing to take effective measures to prevent contraception from the first time when the drug is administered till the last time the drug is administered within 30 days. Female has negative pregnancy tests at the screening stage. Voluntary to sign the informed consent. Exclusion Criteria: Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors. Has a history of drug or food allergy. Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening. Laboratory tests out of normal range and judged by the investigators as clinically significant. Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery. Pregnant, lactating women and people who unwilling to take effective measures to prevent contraception. People who consumed pomelo, apple or orange and foods or drinks containing their extracted ingredients within 3 days of taking the drug. Any prescription or over-the-counter medications, herbs, and vitamins are required to be taken prior to or within the first month of taking the drug. Selected within the first 6 months of smoking, alcohol, drug abuse or history of drug abuse. Selected within the first 3 months had blood loss or blood donation of 200ml. Participate in other clinical trials within the first 3 months of the study and received other study drug treatment. In addition to the above, the investigators judged not suitable for participating in this clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yahong Chen, Master
Organizational Affiliation
Ascletis Pharmaceuticals Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
First Hospital of Zhejiang Province
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34252301
Citation
Wu G, Zhou H, Wu J, Lv D, Wu L, Zhai Y, Lin M, Wu JJ, Shentu J. Pharmacokinetics, Safety, and Tolerability of Ravidasvir, with and without Danoprevir/Ritonavir, in Healthy Subjects. Antimicrob Agents Chemother. 2021 Sep 17;65(10):e0060021. doi: 10.1128/AAC.00600-21. Epub 2021 Jul 12.
Results Reference
derived

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A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

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