Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China

Ascletis

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03020134

ASC162002

Details and patient eligibility

About

The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy Participants

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
• Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG.
• If female, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
• If male, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
• If female, negative pregnancy test during the screening period.
• Others as specified in the detailed protocol

Exclusion criteria

• History or presence of cardiovascular disease, respiratory disease, endocrine and metabolic system disease, urinary system, digestive system, hematological system diseases, nervous system or Psychiatric diseases, and acute or chronic infectious disease and malignant tumor.
• Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab
• History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.
• Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.
• Others as specified in the detailed protocol

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

PKGroup(Ravidasvir/Danoprevir/Ritonavir)

Experimental group

Description:

Ravidasvir + Danoprevir/ Ritonavir

Treatment:

Drug: Danoprevir

Drug: Ritonavir

Drug: Ravidasvir

Placebo Group

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo