HealthyPhase 1NCT03019991
Safety, Tolerability and Pharmacokinetics of Danoprevir/r in Healthy Volunteers China
A Phase 1 study testing 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 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. 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?
- 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
- Oct 2015to Nov 2015
- 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
- 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
Who cannot join
- 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.
About this study
Official title: A Study on Safety, Tolerability and Pharmacokinetics of Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Volunteers
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanoprevirDrug
Also called ASC08
Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13
RitonavirDrug
Also called RTV
Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13
PlaceboDrug
ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13
| Study group | Role | What they receive |
|---|---|---|
| PK Group (Danoprevir,Ritonavir) | Experimental | 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; Receives: Drug: Danoprevir; Drug: Ritonavir |
| Placebo Group | Placebo comparator | 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; Receives: Drug: Ritonavir; 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
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
Measured: Up to 16 days
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state
Measured: Up to 16 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 startOct 2015
- Primary completionNov 2015
- Study completionNov 2015
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
- NCT03019991
- Sponsor's protocol ID
- ASC08201501
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2017
- Last updated
- 13 Jan 2017
- 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 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Safety, Tolerability and Pharmacokinetics of Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03019991
- Acronym / sponsor ID
- ASC08201501
- Conditions
- Healthy
- Keywords
- pharmacokinetics,Danoprevir
- 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
- Oct 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PK Group (Danoprevir,Ritonavir) | Experimental | Drug: Danoprevir, Drug: RitonavirDanoprevir(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; |
| Placebo Group | Placebo comparator | Drug: Ritonavir, Drug: PlaceboASC 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; |
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
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| DanoprevirAlso: ASC08Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13 | Drug | PK Group (Danoprevir,Ritonavir) |
| RitonavirAlso: RTVRitonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13 | Drug | PK Group (Danoprevir,Ritonavir), Placebo Group |
| PlaceboASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13 | Drug | Placebo Group |
Primary outcome
Safety: Incidence of adverse events
Time frame: 40 days
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
Time frame: Up to 16 days
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
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 13 Jan 2017.
- 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 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 6 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 13 Jan 2017. 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). The study lists 3 primary outcomes in all. 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 13 Jan 2017.