HealthyPhase 1NCT03020134
Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China
A Phase 1 study testing Ravidasvir, Danoprevir and Ritonavir in people with Healthy, run by Ascletis Pharmaceuticals Co., Ltd..
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ravidasvir, Danoprevir and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2016to 22 Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide written informed consent
- Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG.
- 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.
- 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.
- If female, negative pregnancy test during the screening period.
- Others as specified in the detailed protocol
Who cannot join
- 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.
- Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab
- History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.
- Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.
- Others as specified in the detailed protocol
About this study
Official title: Phase I Study of Pharmacokinetics and Safety of Ravidasvir in Combination With Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Participants
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavidasvirDrug
Also called ASC16(RDV)
Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23
DanoprevirDrug
Also called ASC08 (DNV)
Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
RitonavirDrug
Also called RTV
Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PKGroup(Ravidasvir/Danoprevir/Ritonavir) | Experimental | Ravidasvir + Danoprevir/ Ritonavir Receives: Drug: Ravidasvir; Drug: Danoprevir; Drug: Ritonavir |
| Placebo Group | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: 40 days
Secondary outcomes (2)
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
Measured: Up to 24 weeks
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state
Measured: Up to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start15 Jul 2016
- Primary completion22 Aug 2016
- Study completion22 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huoling Tang, PhD, Study director, Ascletis Pharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020134
- Sponsor's protocol ID
- ASC162002
- Status last verified
- Nov 2017
- First submitted
- 5 Jan 2017
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Pharmacokinetics and Safety of Ravidasvir in Combination With Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Participants
- ClinicalTrials.gov ID
- NCT03020134
- Acronym / sponsor ID
- ASC162002
- Conditions
- Healthy
- Keywords
- pharmacokinetics, Danoprevir/r, Ravidasvir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 22 Aug 2016 (actual)
- Study completion
- 22 Aug 2016 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PKGroup(Ravidasvir/Danoprevir/Ritonavir) | Experimental | Drug: Ravidasvir, Drug: Danoprevir, Drug: RitonavirRavidasvir + Danoprevir/ Ritonavir |
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing and able to provide written informed consent
- Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG.
- 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.
- 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.
- If female, negative pregnancy test during the screening period.
Key exclusion criteria (5 listed)
- 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.
- Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab
- History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.
- Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.
- Others as specified in the detailed protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RavidasvirAlso: ASC16(RDV)Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23 | Drug | PKGroup(Ravidasvir/Danoprevir/Ritonavir) |
| DanoprevirAlso: ASC08 (DNV)Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23 | Drug | PKGroup(Ravidasvir/Danoprevir/Ritonavir) |
| RitonavirAlso: RTVRitonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23 | Drug | PKGroup(Ravidasvir/Danoprevir/Ritonavir) |
| PlaceboPlacebo | Drug | Placebo Group |
Primary outcome
Safety: Incidence of adverse events
Time frame: 40 days
2 secondary outcomes
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
Time frame: Up to 24 weeks
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state
Time frame: Up to 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huoling Tang, PhD study director
Ascletis Pharmaceuticals Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ravidasvir, Danoprevir and Ritonavir in people with Healthy, run by Ascletis Pharmaceuticals Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of adverse events (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.