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Completed

NCT Number: NCT04547894

A Study of the Pharmacokinetics of ASC09F in Healthy Subjects

The objective of this study is to evaluate the pharmacokinetic parameters of ASC09F in healthy subjects after multiple oral dosing.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Youan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

About this study

This study will evaluate the safety and the pharmacokinetics of ASC09F tablets in healthy volunteers. Subjects will receive 7 days multiple oral doses of ASC09F tablets.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. Age 18-45 (including boundary value), half men and half women. 2. Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).
  • According to the medical history, physical examination, vital signs, laboratory examination and 12 lead electrocardiogram (ECG) examination, the general health condition is good, and there is no clinically significant abnormality in each index.
  • Unplanned pregnancy within half a year and willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration.
  • The pregnancy test of female subjects during the screening period is negative.
  • Those who voluntarily sign the informed consent.

Exclusion criteria

  • 1. Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody were tested positive.
  • People who have taken special diet (including carambola, dragon fruit, mango, grapefruit, orange, etc.) or drunk alcohol, or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 2 weeks before taking the study drug.
  • Heavy smokers (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine;Smoking daily ≥ 5 sticks) and no smoking or alcohol prohibition during the study period.
  • Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.
  • Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.
  • Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.
  • Alcoholic or nonalcoholic fatty liver disease. 8. In addition to the above, the researchers judge that the participants are not suitable to participate in this clinical trial.

Treatment and study plan

ASC09F

Drug

ASC09F (300 mg ASC09 and 100 mg Ritonavir) one tablet at a time, once per day, up to 7 days.

Primary outcomes

  1. AUC of ASC09F

    Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.

    Evaluate the Area under the plasma concentration versus time curve after

  2. Cmax of ASC09F

    Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.

    Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC09F administered to Chinese healthy volunteers.

Secondary outcomes

  1. t1/2 of ASC09F

    Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.

    Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC09F administered to Chinese healthy volunteers volunteers.

  2. CL/F of ASC09F

    Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.

    Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC09F administered to Chinese healthy volunteers.

  3. Vd/F of ASC09F

    Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.

    Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC09F administered to Chinese healthy volunteers.

  4. Evaluation of the safety of ASC09F in healthy volunteers

    Time frame: Up to 11 days

    Evaluate number of adverse events as a measure of safety of ASC09F.

  5. Tmax of ASC09F

    Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.

    Evaluate the Time to reach the maximum plasma concentration after single single and multiple oral doses of ASC09F administered to Chinese healthy volunteers.

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Collaborators

  • Beijing YouAn Hospital

Registry information

Official study title

A Study to Evaluate the Pharmacokinetics of ASC09F in Healthy Subjects After Multiple Doses

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2020
Registry last updated
Jan 11, 2021

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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