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

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ClinicalTrials.gov Identifier: NCT03430830
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis c Drug: Ravidasvir 50mg Drug: Ravidasvir 200mg Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018
Arms and Interventions
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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 Name: ASC16

Drug: Ravidasvir 200mg
200mg, Tablet
Other Name: 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 Name: ASC16

Drug: Ravidasvir 200mg
200mg, Tablet
Other Name: 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 Name: ASC16

Drug: Ravidasvir 200mg
200mg, Tablet
Other Name: 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 Name: ASC16

Drug: Ravidasvir 200mg
200mg, Tablet
Other Name: 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 Name: ASC16

Drug: Ravidasvir 200mg
200mg, Tablet
Other Name: 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 Name: ASC16

Drug: Ravidasvir 200mg
200mg, Tablet
Other Name: ASC16


Outcome Measures
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Primary Outcome Measures :
  1. Peak plasma concentration (Cmax) [ Time Frame: 27 days ]
    Pharmacokinetics (blood draws, pre- and post-dose)

  2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 27 days ]
    Pharmacokinetics (blood draws, pre- and post-dose)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430830


Locations
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China, Zhejiang
First Hospital of Zhejiang Province
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
Investigators
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Study Director: Yahong Chen, Master Ascletis Pharmaceuticals Co., Ltd.
More Information
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03430830    
Other Study ID Numbers: ASC-ASC16-I-CTP-03
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic