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OpenTrials
Completed

NCT Number: NCT03019991

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Danoprevir

Drug

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

Other names: ASC08

Ritonavir

Drug

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

Other names: RTV

Placebo

Drug

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

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 40 days

  2. Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)

    Time frame: Up to 16 days

  3. 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

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2017
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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