Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-04-15 @ 12:28 AM
Study NCT ID:
NCT03020134
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2017-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621711', 'term': 'ravidasvir'}, {'id': 'C553752', 'term': 'danoprevir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-27', 'studyFirstSubmitDate': '2017-01-05', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': '40 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state', 'timeFrame': 'Up to 24 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'Danoprevir/r', 'Ravidasvir'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy Participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG.\n* If female, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.\n* If male, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.\n* If female, negative pregnancy test during the screening period.\n* Others as specified in the detailed protocol\n\nExclusion Criteria:\n\n* 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.\n* Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab\n* History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.\n* Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.\n* Others as specified in the detailed protocol'}, 'identificationModule': {'nctId': 'NCT03020134', 'briefTitle': 'Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascletis Pharma Inc'}, 'officialTitle': 'Phase I Study of Pharmacokinetics and Safety of Ravidasvir in Combination With Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Participants', 'orgStudyIdInfo': {'id': 'ASC162002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PKGroup(Ravidasvir/Danoprevir/Ritonavir)', 'description': 'Ravidasvir + Danoprevir/ Ritonavir', 'interventionNames': ['Drug: Ravidasvir', 'Drug: Danoprevir', 'Drug: Ritonavir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ravidasvir', 'type': 'DRUG', 'otherNames': ['ASC16(RDV)'], 'description': 'Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23', 'armGroupLabels': ['PKGroup(Ravidasvir/Danoprevir/Ritonavir)']}, {'name': 'Danoprevir', 'type': 'DRUG', 'otherNames': ['ASC08 (DNV)'], 'description': 'Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23', 'armGroupLabels': ['PKGroup(Ravidasvir/Danoprevir/Ritonavir)']}, {'name': 'Ritonavir', 'type': 'DRUG', 'otherNames': ['RTV'], 'description': 'Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23', 'armGroupLabels': ['PKGroup(Ravidasvir/Danoprevir/Ritonavir)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Huoling Tang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ascletis Pharmaceuticals Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascletis Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}