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

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;
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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;
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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 |
- 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 ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Study Director: | Huoling Tang, PhD | Ascletis Pharmaceuticals Co., Ltd. |
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 |
pharmacokinetics,Danoprevir |
Ritonavir HIV Protease Inhibitors Viral 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 |