Safety, Tolerability and Pharmacokinetics of Danoprevir/r in Healthy Volunteers China

Ascletis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Ritonavir; Drug: Danoprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT03019991

ASC08201501

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

PK Group (Danoprevir,Ritonavir)

Experimental group

Description:

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;

Treatment:

Drug: Ritonavir

Drug: Danoprevir

Placebo Group

Placebo Comparator group

Description:

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;

Treatment:

Drug: Placebo

Drug: Ritonavir