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

June 27, 2018 updated by: Ascletis Pharmaceuticals Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • First Hospital of Zhejiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GROUP 1
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.
Drug: Ravidasvir 50mg
50mg, Tablet
Other Names:
  • ASC16
Drug: Ravidasvir 200mg
200mg, Tablet
Other Names:
  • ASC16
EXPERIMENTAL: GROUP 2
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.
Drug: Ravidasvir 50mg
50mg, Tablet
Other Names:
  • ASC16
Drug: Ravidasvir 200mg
200mg, Tablet
Other Names:
  • ASC16
EXPERIMENTAL: GROUP 3
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.
Drug: Ravidasvir 50mg
50mg, Tablet
Other Names:
  • ASC16
Drug: Ravidasvir 200mg
200mg, Tablet
Other Names:
  • ASC16
EXPERIMENTAL: GROUP 4
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.
Drug: Ravidasvir 50mg
50mg, Tablet
Other Names:
  • ASC16
Drug: Ravidasvir 200mg
200mg, Tablet
Other Names:
  • ASC16
EXPERIMENTAL: GROUP 5
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.
Drug: Ravidasvir 50mg
50mg, Tablet
Other Names:
  • ASC16
Drug: Ravidasvir 200mg
200mg, Tablet
Other Names:
  • ASC16
EXPERIMENTAL: GROUP 6
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.
Drug: Ravidasvir 50mg
50mg, Tablet
Other Names:
  • ASC16
Drug: Ravidasvir 200mg
200mg, Tablet
Other Names:
  • ASC16

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak plasma concentration (Cmax)
Time Frame: 27 days
Pharmacokinetics (blood draws, pre- and post-dose)
27 days
Area under the plasma concentration versus time curve (AUC)
Time Frame: 27 days
Pharmacokinetics (blood draws, pre- and post-dose)
27 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

Investigators

  • Study Director: Yahong Chen, Master, Ascletis Pharmaceuticals Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2018

Primary Completion (ACTUAL)

April 9, 2018

Study Completion (ACTUAL)

April 9, 2018

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (ACTUAL)

February 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC-ASC16-I-CTP-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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