Clinical trial NCT03019991: Safety, Tolerability and Pharmacokinetics of Danoprevir/r in Healthy Volunteers China
Official title: A Study on Safety, Tolerability and Pharmacokinetics of Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics,Danoprevir
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 40 days
measure: Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
timeFrame: Up to 16 days
measure: Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state
timeFrame: Up to 16 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ascletis Pharmaceuticals Co., Ltd.
name: Huoling Tang, PhD
role: STUDY_DIRECTOR
References: