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Safety, Tolerability and Pharmacokinetics of Danoprevir/r in Healthy Volunteers China

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ClinicalTrials.gov Identifier: NCT03019991
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : January 13, 2017
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 of Danoprevir in single dose (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4 and day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study on Safety, Tolerability and Pharmacokinetics of Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Volunteers
Study Start Date : October 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ritonavir

Arms and Interventions
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Arm Intervention/treatment
Experimental: PK Group (Danoprevir,Ritonavir)
Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14;100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13;
 Drug: Danoprevir
Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13
Other Name: ASC08

Drug: Ritonavir
Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13
Other Name: RTV
Placebo Comparator: Placebo Group
ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13 for 14 days;
 Drug: Ritonavir
Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13
Other Name: RTV

Drug: Placebo
ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 40 days ]
  2. Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max) [ Time Frame: Up to 16 days ]
  3. Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state [ Time Frame: Up to 16 days ]

Eligibility Criteria
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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:

  • Willing and able to provide written informed consent
  • Healthy men or women based on history, physical examination, laboratory examination and ECG.
  • Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs
  • Female patients with childbearing potential (menopause within 1 year) must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment and for at least 6 months following the last dose of ribavirin
  • All male patients with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin
  • Others as specified in the detailed protocol

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.
  • Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery.
  • Pregnant, lactating or menstrual period and unwilling to reliable contraception period women of childbearing age.
  • Female partners have fertility and reliable contraceptive measures of men.
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): NCT03019991


Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
Investigators
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Study Director: Huoling Tang, PhD Ascletis Pharmaceuticals Co., Ltd.
More Information
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03019991    
Other Study ID Numbers: ASC08201501
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ascletis Pharmaceuticals Co., Ltd.:
pharmacokinetics,Danoprevir
Additional relevant MeSH terms:
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Ritonavir
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