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Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

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ClinicalTrials.gov Identifier: NCT03288636
Recruitment Status : Completed
First Posted : September 20, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

Brief Summary:
The purpose of this study is to investigate the Pharmacokinetics and Safety of single dose of Ravidasvir and Danoprevir/r and repeated doses of Ravidasvir in combination with Danoprevir/r in healthy volunteers.

Condition or disease Intervention/treatment Phase
HCV Drug: Danoprevir Drug: Ritonavir Drug: Ravidasvir Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Study to Assess the Pharmacokinetics and Safety of Single Dose of Ravidasvir and Danoprevir/r and Repeated Doses of Ravidasvir in Combination With Danoprevir/r in Healthy Volunteers.
Actual Study Start Date : August 8, 2017
Actual Primary Completion Date : September 14, 2017
Actual Study Completion Date : October 28, 2017

Arm Intervention/treatment
Experimental: Experimental

PKGroup:

Ravidasvir + Danoprevir/ Ritonavir

Drug: Danoprevir
Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23

Drug: Ritonavir
Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23

Drug: Ravidasvir
Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23
Other Name: ASC16(RDV)

Placebo Comparator: Placebo

Placebo Group:

Placebo

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 40 days ]
    Incidence of adverse events



Information from the National Library of Medicine

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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 19~28kg/m2
  • Healthy men or women based on history, physical examination, laboratory examination and ECG.
  • Female subjects should be surgically sterilized (bilateral tubal ligation, bilateral ovariectomy or hysterectomy); or are willing to use at least one of the following contraceptive methods within 30 days of the first administration of the study drug until the last administration: I Male partner vas deferens ligation; II. Non-hormonal contraceptive methods: intrauterine contraceptives, condoms, contraceptive sponges, septa, vaginal ring containing sizing gel or cream.
  • Male subjects should be surgically sterilized; or are willing to use at least one of the following contraceptive methods within 30 days from the first administration of the study to the last administration: I. Female partners abstinence during the study period (including no donation): II. Compounds use hormonal contraceptives (oral, vaginal, parenteral or transdermal); III. Subjects and / or their female partners use non-hormonal contraceptive methods: condoms, contraceptive sponges, membranes, intrauterine devices, Fine gel or cream of the vaginal ring.
  • If female, the pregnancy test result should be negative during the screening period.
  • Voluntary to sign the informed consent.

Exclusion Criteria:

  • History or presence of cardiovascular disease, respiratory disease, endocrine and metabolic system disease, urinary system, digestive system, hematological system diseases, nervous system or Psychiatric diseases, and acute or chronic infectious disease and malignant tumor.
  • A history of drug or food allergy.
  • Positive test in any of the HBsAg、HCV Ab、HIV Ab and Syphilis Ab.
  • Any of the AST、ALT、ALP、TBIL and DBIL exceed the upper limits of normal, or other laboratory test results exceeding the normal range and judged by the investigator to be clinically significant.
  • History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.
  • Female who were during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.
  • Female partners were fertile and unwilling to take reliable contraceptive measures.
  • Others as specified in the detailed protocol.

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): NCT03288636


Locations
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China, Zhejiang
The first hospital of Zhejiang province
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.

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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03288636     History of Changes
Other Study ID Numbers: ASC-ASC16-I-CTP-02
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: October 2017
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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Ritonavir
Lactams
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents