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Trial record 1 of 1 for:    NCT04547894
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A Study of the Pharmacokinetics of ASC09F in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04547894
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
Beijing YouAn Hospital
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: ASC09F Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Pharmacokinetics of ASC09F in Healthy Subjects After Multiple Doses
Actual Study Start Date : November 9, 2020
Actual Primary Completion Date : December 7, 2020
Actual Study Completion Date : December 7, 2020

Arm Intervention/treatment
Experimental: ASC09F
ASC09F one tablet at a time, once per day, up to 7 days.
Drug: ASC09F
ASC09F (300 mg ASC09 and 100 mg Ritonavir) one tablet at a time, once per day, up to 7 days.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

    3. 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.

    4. 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.

    5. The pregnancy test of female subjects during the screening period is negative.

    6. 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.

    2. 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.

    3. 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.

    4. Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.

    5. Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.

    6. Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.

    7. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547894


Locations
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China, Beijing
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing, China, 100069
Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
Beijing YouAn Hospital
Publications:
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04547894    
Other Study ID Numbers: ASC-ASC09F-I-CTP-01
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No