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

A Study on Safety, Tolerability and Pharmacokinetics of Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03019991

Enrollment

Registered

2017-01-13

Start date

2015-10-31

Completion date

2015-11-30

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

pharmacokinetics,Danoprevir

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.

Interventions

DRUGDanoprevir

Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13

DRUGRitonavir

Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13

DRUGPlacebo

ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	40 days
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)	Up to 16 days
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state	Up to 16 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026